19-20 October 2011_ Maritim proArte Hotel_ Berlin_ Germany

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19-20 October 2011_ Maritim proArte Hotel_ Berlin_ Germany Powered By Docstoc
					Europe’s No 1 Biomanufacturing Event                                                                                         Increase productivity
                                                                                                                            and reduce costs with
                                                                                                                                 55 case studies +
                                                                                                                                   feedback from
                                                                                                                                          FDA and
                                                                                                                                            MHRA




19-20 October 2011, Maritim proArte Hotel, Berlin, Germany
 Discover the latest tools, technologies and processes optimising bioproduction,
 ensuring product quality, process efficiency and regulatory success

 Global Panel of Senior Level Decision-Makers from Industry’s Most Distinguished Companies, Regulators and Academics
          Dr Paul Varley,                  Dr Keith Chidwick,                    Dr Gert Mølgaard,                    Professor Jürgen Hubbuch,
          VP, Biopharm                     Senior Pharmaceutical                 VP, Strategic Development,           Professor,
          Development,                     Assessor,                             NNE Pharmaplan,                      Karlsruher Institut für
          MedImmune, UK                    MHRA, UK                              Denmark                              Technologie (KIT), Germany
          Mrs Ellen McCormick,             Professor Florian Wurm,               Dr Hans-Martin Mueller,              Dr Sheryl Martin-Moe,
          Senior Director,                 Swiss Federal Institute               Global Head,                         Global Head Biologics
          Bio-Manufacturing Sciences,      of Technology Lausanne                Biotech GMP,                         Pharmaceutical Development,
          Pfizer, USA                      Switzerland                           Merck, Switzerland                   Novartis, Switzerland


70+ Speakers • 55+ Case Studies • 40+ Hours of New Science • 11+ Hours Networking Time • 5 Interactive Panels

NEW FOR 2011:
• 10+ data-driven sessions on biosimilars, manufacturability,                    • On-stage plenary interviews with key figures from
  novel therapies, new technologies, low-cost expression systems,                  Pfizer, GSK and MedImmune
  formulation…plus many more                                                     • SME Licensing and Partnering Workshop
• 5 interactive panels on process validation, supplier prequalification,         • Free Training Seminar on “How to Manage an
  QbD, biosimilars and ICH Q11                                                     Effective Team”
• Regulatory feedback from MHRA and FDA on implementing QbD
                                                                                                                           50% Discount for
                                                                                                                           SME Companies
Key Reasons Why You HAVE to Attend:                                        Choice of 6 Practical Workshops
 Discover the latest manufacturing technologies driving                    Pre-Conference Workshops • Tuesday 18 October 2011
 the production of antibodies, antibody variants, vaccines and                 Comparability: Strategies for Scaling Up and Other
 recombinant proteins                                                          Process Changes
 Ensure the highest quality manufacturing standards                            Implementation of QbD for Biopharmaceuticals
 by implementing best practices in Quality by Design and                       Product Characterisation of Biopharmaceuticals
 Process Validation, plus latest updates on the forthcoming
 ICH Q11 guideline                                                         Post-Conference Workshops • Friday 21 October 2011
 Screen out inefficient processes and candidates by                            Biosimilar Monoclonal Antibodies in the EU and US –
 designing “manufacturability” and “developability” in your                    From Development to Market
 early-stage development programmes                                            Understanding Aggregation and Devising Preventative Methods
 Successfully audit your single-use suppliers to ensure                        Single Use vs. Stainless Steel: Impact on Design of Flexible
 quality and effective change management – join the debate                     Modular-Based Facilities
 with key end-users and vendors
 Take advantage of the lucrative biosimilars market                        The agenda for BioProduction 2011 is one of
 with in-depth technical insight from Merck, Dr Reddy’s and
 Sandoz, plus latest regulatory feedback on the impending                  the best I’ve seen in a long time - the topics
 European mAb biosimilar guideline                                         are highly relevant and reflect the challenges
 Overcome the unique manufacturing challenges facing                       faced by the industry
 the development of novel therapies such as bi-specifics,                  Dr Ivan R Correia, Principal Research Scientist, Abbott, USA
 antibody fragments, combination antibodies and ADCs                       - 2011 Advisor
 Find novel analytical and formulation approaches for
 improving bioprocessing and optimsing product quality
                                                                                                 www.bio-production.com
Produced by:                   Part of:                              Corporate Sponsor                                         Associate Sponsors




                                                           To Register Please Tel: +44 (0)20 7017 7481
                                      Fax: +44 (0)20 7017 7823 Email: registrations@informa-ls.com
                                               Web: www.bio-production.com Please quote: CQ3446
                                                                                This conference is the ideal opportunity to meet and
                                                                                network with the established players in the industry
19-20 October 2011, Maritim proArte Hotel, Berlin, Germany                      Dr Tony Hitchcock, Head of Manufacturing Technologies, RecipharmCobra Biologics, UK




  Dear Biomanufacturing Professional,
  Through a combination of 70+ speakers, 55 case studies, 8 keynote sessions, 5 interactive panel sessions and 11 hours of exclusive networking activities,
  BioProduction 2011 brings together the leading decision-makers from across industry and academia to set the agenda for the biopharmaceutical community
  and drive improvements in the development, production and quality of life saving therapies.

  Key highlights of BioProduction 2011
    The largest European biomanufacturing event this year - All your peers will be there!
    Our most senior level speaker line up ever! - 65% of speakers are Director level or above; 33% VPs or SVPs
    The conference of choice for FDA and MHRA regulators - Offering advice on implementing QbD
    Brand new sessions on: Biosimilars, novel therapies, new manufacturing technologies, low-cost expression systems, manufacturability, continuous
    manufacturing, supplier pre-qualification...and many more
    New interactive formats - Expert led panel sessions and On-Stage Interviews with Directors and VPs from GSK, MedImmune and Pfizer
    Inspirational presentation from Simon Weston on succeeding in the face of adversity

  11 Hours of Extensive Networking and Partnering Time
  Before the Event
  Use our NEW Online Networking Tool to arrange meetings prior to arriving at the event

  During the Event
  • Speed Networking – Make more business contacts in 30 minutes than most people make in 6 months - Day 1, 16.15
  • Drinks Reception – Chances are you’ll meet lots of people who you wish you had more time to speak to;
    Do so by attending our Exhibition Drinks Reception at the end of Day One

                              • Networking Dinner -
                                Please join us on Wednesday 19 October 2011 for our networking dinner
                                at Restaurant Nolle, offering international and Berlin cuisine and classic
                                beverages in a unique and historical setting.

                                             Limited places are available so book early – Cost is included
                                             in the conference fee (not applicable if booked via a sponsor
                                             or exhibitor contract) (Sold out last year so book early)




                                              Follow us on Twitter:
                                               @Bioproduction11

  After the Event
  • Join the BioProcessing Professionals Europe LinkedIn Group
    for post event announcements and to keep up with the people
    you met from 2 days of productive networking.                     Join our event Community


  Submit a Poster and Share your Latest Scientific Data
  In recognition of the significant educational impact and value poster presentations
  provide our attendees, the organisers at BioProduction have created the 2011
  BioProduction Best Poster Award.

  Key poster topics requested by the Advisory Board this year include:
  • New Technologies in Upstream/Downstream Processing
  • Novel disposable technologies
  • New Analytical Approaches
  To apply please send your abstract of 200 words or less, written in English, listing the principle author and all contact details to daniel.barry@informa.com

  Last date for submission is Friday 14 October 2011
  • Posters submitted by academics, biopharmaceutical and pharmaceutical organisations will not be charged a fee
  • Posters submitted by service providers/vendors are welcome and will be subject to evaluation by the scientific advisory board.
    Upon approval a fee of £399 + VAT will apply
  • Posters will be 1m x 1.5m portrait and held in the exhibition

  Don’t miss out on the must- attend event of 2011, we look forward to meeting you in Berlin!

  The 2011 BioProduction Scientific Advisory Board

  Dr Alahari Arunakumari, President, AHA Bioconsultants, USA                           Dr Alistair Kippen, Director, Analytical Biochemistry R&D, MedImmune, UK
  Dr Julio Baez, VP, Biologics, Richmond Chemical, USA                                 Dr Morten Munk, VP, BD and Technology Specialist, CMC Biologics,
  Dr James Blackwell, Senior Consultant, Bioprocess Technology Consultants, USA        Co-Chair of PDA Task Force for Single Use Systems, Denmark
  Dr Stephen Brown, CTO, Vivalis, France                                               Dr Andrew Sinclair, President and Founder, Biopharm Services, UK
  Dr Christine Chan, Senior Manager, Genzyme, USA                                      Dr Bill Thompson, Consultant, Rotherwood Consultants, UK
  Dr Ivan Correia, Principal Scientist, Abbott, USA                                    Dr Karin Wassard, Senior Consultant, NNE Pharmaplan, Denmark
  Dr Tony Hitchcock, Head of Manufacturing Technologies,                               Dr Peter Watler, CTO, Hyde Engineering + Consulting, USA
  RecipharmCobra Biologics, UK                                                         Dr Edward Zartler, Research Fellow, Merck, USA
                                                                                       Dr Jesus Zurdo, Head of Innovation LCM Development, Lonza, UK




                                                 To Register Please Tel: +44 (0)20 7017 7481 Fax: +44 (0)20 7017 7823
                                                                                                                                 This agenda exactly mirrors the current
                                                                                                                                 challenges faced by many companies
  19-20 October 2011, Maritim proArte Hotel, Berlin, Germany                                                                     Dr James Blackwell, Senior Consultant, BioProcess Technology Consultants, USA


  OPENING PLENARY ON TRENDS AND OPPORTUNITIES IN BIOPRODUCTION
  07:30                                                                                                                            10.10
  Morning Coffee and Registration                                                                                                  On-Stage Plenary Interview with Pfizer, GSK and MedImmune - New for 2011!
  09.00                                                                                                                            Following directly on from the plenary session, chairman, John Birch, speaks with Paul Varley, Ellen McCormick
                                                                                                                                   and Director of Biopharm Process Research at GSK, Mark Uden, about the critical challenges facing the today’s
  Chairperson’s Opening Remarks and Welcome Address
                                                                                                                                   bioproduction professionals, from cost pressures to next-generation therapies driving company pipelines –
  Dr John Birch, Independent Consultant, Former CSO, Biopharmaceuticals, Lonza Biologics, UK                                       submit your question in advance by visiting our website today.
  09.05                                                                                                                            Proposed topics include:
  From antibodies to novel therapies: What lessons can we learn from our existing knowledge base?                                  • What are the main challenges currently facing bioproduction?
  The last two decades has seen continued advances in process development and manufacturing of antibody therapeutics,              • What new technologies/systems are driving forward bioproduction
  driven by the number of marketed products and the potential of those in development. This talk will examine what we              • Where can cost savings be made?
  can learn from these advances to drive the development of the next generation of novel protein pharmaceutical products.          • Therapies of the future?
         Dr Paul G. Varley,                                                                                                        • Biosimilars – if you can’t beat then, should you join them?
         Vice President, Biopharmaceutical Development,                                                                            Panelists:
         MedImmune, UK                                                                                                                    Dr John Birch,
                                                                                                                                          Independent Consultant, Former CSO, Biopharmaceuticals,
  09.35
                                                                                                                                          Lonza Biologics, UK
  Integration challenges: Strategies and structures to blend two development manufacturing
  organisations                                                                                                                    Dr Paul G. Varley, Vice President, Biopharmaceutical Development, MedImmune, UK
  Expertise and capabilities in process development and supply provide a competitive advantage for Pfizer.                         Mrs Ellen McCormick, Senior Director, Bio-Manufacturing Sciences, Pfizer, USA
  This talk will review Pfizer Biotherapeutics supply network strategy in the new combined company.                                Dr Mark Uden, Director, Biopharm Process Research, GSK, UK
  The optimised network emphasises a company culture of collaboration and flexible supply organisational design.                                                                                      Are you an SME looking to license
                                                                                                                                   10.35
                                                                                                                                                                                                      out a technology or product?
          Mrs Ellen McCormick,                                                                                                     Morning Coffee and Poster/Exhibition Viewing Time
                                                                                                                                                                                                      If so, join our free SME partnering workshop running
          Senior Director, Bio-Manufacturing Sciences,
                                                                                                                                                                                                      concurrently to the plenary session (see page 6)
          Pfizer, USA


   Improve Productivity:                                           Ensure Product Quality:                                          Reduce Costs: Evaluate                                        Create Opportunities in
   Upstream and Downstream                                         QbD, CQAs, Design                                                Disposables, Supply                                           Bioproduction: Biosimilars,
   Innovations for Antibodies,                                     Space, Process Validation                                        Chain Security, Flexible,                                     Analytics, Formulation,
   Bi-Specifics, Vaccines,                                         and ICH Q11                                                      Continuous Manufacturing                                      Cell Therapies
   Recombinant Proteins
                                                                    Successfully Rank and Set CQAs, CPPs,                               Effectively Audit Your Single-Use                          Regulatory Pathways for Getting
     Designing “Manufacturability”                                  Design Space and Control Strategies                                 Suppliers to Ensure Quality and                            Biosimilars to Market in the EU and US
     into Products and Processes                                                                                                        Effective Change Management
                                                                   By attending this session you will:                                                                                            By attending this session you will:
                                                                   • Benchmark your QbD strategies against market leaders           By attending this session you will:                           • Hear the latest regulatory update on mAb
   By attending this session you will:                                                                                                                                                              biosimilar guidelines
                                                                   • Develop reliable design space to successfully                  • Conduct a thorough due diligence of suppliers
   • Screen out ineffective processes and avoid                                                                                                                                                   • Take lead on market opportunities in biosimilars
                                                                     implement QbD                                                  • Confidently deal with change controls
     late-stage delays
                                                                                                                                    • Ensure a secure supply chain                                11.25
   • Reduce timelines and product attrition rates                  11.25
   • Hear Novartis’ and MedImmune’s approach                       Generation and uses of a Critical Quality                        11.25                                                         Update on the impending European mAbs
     to “manufacturability”                                        Attribute Risk Assessment: The importance                        Disposables implementation challenges and                     Biosimilar Guideline
                                                                   of collaboration between functional areas                        supplier risk assessment for Pierre Fabres’                   • Update on EU biosimilar monoclonal antibody guideline
   11.25
                                                                   Performing the CQA Risk Assessment, with broad                   new clinical trials facility                                  • Feedback on industry comments
   FEATURED PRESENTATION                                                                                                                                                                          • Discussion on the key requirements
                                                                   representation from the Development Team is                      This presentation will describe Pierre Fabres’ project
   What are critical, early-stage manufacturing                    important in ensuring that the potential impact of               management approach to a fast track implementation            • Regulatory standards for approval
   decisions that need to be made to ensure                        quality attributes on safety and efficacy are considered         of disposable technologies throughout their clinical          Dr Lincoln Tsang, Partner, Arnold and Porter LLP, UK
   late-stage success?                                             by all stakeholders (Discovery, Toxicology, Clinical, etc).      trials manufacturing process. Key aspects that will be
   (see www.bio-production.com for more information)               A CQA Risk Assessment generated in such a way aids in            addressed in this presentation include critical disposable    12.00
   Dr Gregory MacMichael, Global Head, Biologics                   the prioritisation of development activities, which should       technologies supplier risk assessment. Disposable supplier    The new US Biosimilar Act - What does it
   Process R&D, Novartis, Switzerland                              lead to an improved understanding of product structure-          prequalification: manufacturing, quality and supply chain.    all mean?
                                                                   function relationships and a robust control strategy.            Dr Jean-Claude Corbières, Pierre Fabre Centre for             The Biologics Price Competition and Innovation Act of
   12.00                                                                                                                                                                                          2009 (Biosimilars Act) has provided, for the first time, an
                                                                   Dr Taro Fujimori, Associate Director, CMC Projects,              Immunology, France
   Biophysical screening of protein                                Abbott Biologics Manufacturing, USA                                                                                            abbreviated regulatory pathway for follow-on biological
   manufacturability                                                                                                                Dr Miriam Monge, Vice President Marketing &
                                                                                                                                    Bioprocess Applications, Biopharm Services, UK                products. The Biosimilars Act has unique provisions,
   Biophysical analysis of therapeutic proteins is leading to a    12.00                                                                                                                          such as a provision that requires that the biosimilar
   better understanding of the factors and mechanisms that         An approach to develop reliable design                           12.00                                                         applicant disclose the process for making the product
   lead to protein stability problems such as aggregation.         space for successful implementation of QbD                       Ensuring secure supply chain management                       to the approval holder. An overview of the legal
   A biophysical analysis of the solution structures present       Design space is one of key elements of QbD and                   between supplier and end-user                                 requirements for an application of a biosimliar biologic,
   for an IgG4 antibody under various conditions will be           therefore, it is highly essential to apply a well-organised                                                                    including intellectual property implications are reviewed.
                                                                                                                                    • Controlling raw materials
   presented and the potential role of conformational              DOE approach. Appropriate statistical tools, prior                                                                             Dr Paul Calvo, Attorney, Sterne, Kessler, Goldstein
   changes upon aggregation will be discussed. Techniques                                                                           • Due diligence of suppliers
                                                                   knowledge integration, systematic design selection,              • What controls does the supplier have in place               & Fox P.L.L.C., USA
   for rapidly screening small quantities of proteins to           careful execution and logical interpretation of results
   assess their manufacturability will also be presented.                                                                           • What level of validation have they done -                   12.35
                                                                   followed by confirmation can develop an accurate and               particulates, leachables
   Dr Paul Dalby, Department of Chemical Engineering,              reliable Design space. This presentation gives a simplistic                                                                    Discussion Panel - Biosimilars
                                                                                                                                    • How do the suppliers react when there is a change
   UCL, UK                                                         overview of QbD and includes case studies describing                                                                           • What will it take for biosimilar mAbs to succeed?
                                                                                                                                      control – do they have to tell you?
                                                                   challenges during development of successful design space.                                                                      • What are the non-clinical and clinical requirements
   12.35                                                                                                                            Dr Peter Watler, CTO, Hyde Engineering +
                                                                   Dr Mayank Garg, Manager, Manufacturing Sciences,                                                                                  for biosimilar mAbs medicines?
   Strategies for design and screening for                                                                                          Consulting, USA
                                                                   Dr Reddy’s, India                                                                                                              • What manufacturing, analytical and formulation
   manufacturability attributes before early                                                                                        12.35                                                            issues need to be taken into consideration?
   stage development                                               12.35                                                            Discussion Panel - Keeping on top of this                     • Discussion on the US biosimilar route
   Improving the predictability of biopharmaceutical protein       How to implement QbD in Process – a case study                   disposables supply chain                                      • Does the cost of developing biosimilars make
   drug manufacture can be influenced at an early project          To manage implementation of QbD it is vital to understand                                                                         commercial sense, and for what indications?
   stage. For example, the design or screening of the primary                                                                       • How are companies monitoring suppliers? Internal audits
                                                                   the technical requirements and the implications in this          • How can end-users keep on top of changes made               • Biosimilar vs. biosuperior – which route is best to
   amino acid sequence of a candidate protein therapeutic          framework. We will show with a real example how                                                                                   take and why?
   molecule can reduce the risk of undesirable biophysical                                                                             by suppliers?
                                                                   common technologies as DOE, Monte Carlo Simulations              • Qualifying suppliers and secondary suppliers                Dr Hans-Martin Mueller, Global Head, Biotech GMP,
   effects during manufacture. A key factor is combining           and MVA can be used for a successful QbD implementation.         • Problems when using a variety of suppliers                  Merck, Switzerland
   this approach with an efficient laboratory screen, using
   representative scaled-down platform protein production          Dr Conny Wikström, Senior Application Specialist,                • Due diligence for suppliers                                 Dr Lincoln Tsang, Partner, Arnold and Porter, UK
   systems, at a sufficiently early (pre-development) project      Product Manager, Umetrics, Sweden                                Dr Peter Watler, CTO, Hyde Engineering +                      Dr Keith Chidwick, Senior Pharmaceutical Assessor,
   stage. Some examples will be given.                                                                                              Consulting, USA                                               MHRA, UK
                                                                   13.10
   Dr Ray Field, Director, Cell Sciences and CMC                                                                                    Dr Robert Steinberger, SVP, Acceleron, USA                    Dr Carsten Brockmeyer, Biosimilar Expert & Managing
                                                                   Lunch and Poster/Exhibition Viewing Time
   Team Leader, Biopharmaceutical Development,                                                                                                                                                    Director, Brockmeyer Biopharma, Germany
                                                                                                                                    Dr Miriam Monge, Vice President Marketing &
   MedImmune, UK                                                                                                                    Bioprocess Applications, Biopharm Services, UK                Dr Paul Calvo, Attorney, Sterne, Kessler, Goldstein
                                                                    Meet FDA and MHRA Requirements                                                                                                & Fox P.L.L.C., USA
   13.10                                                                                                                            Dr Jean-Marc Cappia, Group Vice President,
                                                                    for QbD                                                         Marketing and Product Management,                             13.10
   Lunch and Poster/Exhibition Viewing Time
                                                                                                                                    Sartorius Stedim Biotech, France                              Lunch and Poster/Exhibition Viewing Time
                                                                   By attending this session you will:
     Optimise Upstream Processing Using                            • Meet the FDA and MHRA requirements for QbD                     13.10
     Low-Cost Expression Systems                                   • Hear about QbD fillings currently with the agencies            Lunch and Poster/Exhibition Viewing Time                       CMC Challenges when Developing
                                                                   • Discover the minimal requirements for QbD                                                                                     Biosimilars
   By attending this session you will:                             14.30                                                                Evaluate and Implement Disposables
   • Implement rapid, low-cost expression systems                                                                                                                                                 By attending this session you will:
                                                                   Quality-by-Design for biotechnology                                                                                            • Understand the potential “shortcuts” that can be
   • Follow Abbot’s lead and successfully develop a                                                                                 By attending this session you will:
                                                                   products: Notes from the pilot program –                                                                                         taken when developing biosimilars
     chemically-defined cell culture platform                                                                                       • Hear how Merck and Roche compare and implement
                                                                   Initial results, next steps                                        disposables                                                 • Meet strict comparability standards for biosimilars
   • Optimise your process and reduce costs using lean
     manufacturing and RNAi                                        Quality by Design (QbD) is defined as a systematic               • Be fully up-to-date with PDA’s recommendations on SUS       • Hear in-depth case studies from companies already
                                                                   approach to development that begins with predefined                                                                              in the biosimilar space
   14.30                                                           objectives and emphasises product and process                    14.30
   KEYNOTE: Transient gene expression                              understanding and process control, based on sound                A comparative analysis of single-use                          14.30
   yesterday, today and tomorrow -                                 science and quality risk management. Some initial lessons        bioreactors to understand the most                            FEATURED PRESENTATION
   a role for manufacturing?                                       learned from the US FDA’s pilot program on the application       effective implementation                                      Quality control and analytical development
   Transient gene expression is the fastest approach to protein    of QbD to biotechnology products will be discussed.              The quality of the molecule together with the molecule        of biosimilars
   synthesis. It provides huge benefits in insights on structure   Dr Barbara Rellahan, FDA, USA                                    titer and the cell growth was compared between                In contrast to developing originator products, biosimilars
   and function when executed at small scale. Now, with                                                                             the 6 single use technologies. An evaluation grid             are following abbreviated development procedures. In
   new technologies developed in our labs, transfected DNA                                                                          was applied to choose the best disposable bioreactors         order to cope with abbreviated timelines and “shortcut”
   translates into protein within hours, therapeutic protein         A timely, comprehensive                                        which allowed Merck Serono Biodevelopment to                  approaches, appropriate strategies needs to be in place
                                                                                                                                                                                                  to generate high quality analytical filing data. This
   candidates can yield 0.5-2.0 g/L from HEK-293 and CHO                                                                            conclude on disposable bioreactors uses and on the
   cells in simple reactor systems over a short batch or fed         agenda… great to see the                                       scalability (up and down) of these disposable systems.        presentation will look at: Strategic considerations when
   batch culture. How close are we in bringing this technology                                                                      Dr Aurore Lahille, Specialist, New Technologies and           developing biosimilars; Appropriate risk approaches and
   to the manufacturing world? What would be the benefits?           MHRA and FDA represented                                       Manufacturing Support, Merck Serono, France                   efficiency development concepts.
           Professor Florian M. Wurm, Swiss Federal                  Dr Alistair Kippen, Director R&D,                                                                                                    Dr Hans-Martin Mueller,
           Institute of Technology Lausanne (EPFL)                   Analytical Biochemistry, MedImmune, UK                                                                                               Global Head, Biotech GMP,
           and ExcellGene SA, Switzerland                                                                                                                                                                 Merck, Switzerland




Email: registrations@informa-ls.com Web: www.bio-production.com Please quote: CQ3446                                                                                                                                                                            3
                                                                                                                               A great opportunity to network with like-minded
                                                                                                                               professionals and debate hot topics
    19-20 October 2011, Maritim proArte Hotel, Berlin, Germany                                                                 Dr Bill Thompson, Owner, Rotherwood Consultants, UK


     Media Development,                                             MHRA, FDA Feedback;                                         Evaluating and                                                   CMC Issues For Biosimilars
     Lean Manufacturing                                             Minimal Requirements                                        Implementing Disposables                                         15.05
     and RNAi                                                       for QbD                                                      15.05
                                                                                                                                                                                                 Analytical structural characterisation for
                                                                                                                                                                                                 comparability purposes
     15.05                                                          15.05                                                        Process4Success - Platforms for single-use
                                                                                                                                                                                                 Any manufacturer seeking to market a biopharmaceutical
     Development and implementation of a novel                      QbD for biologics – A European agency’s view                 biomanufacturing
                                                                                                                                                                                                 product requires comprehensive physicochemical
     chemically-defined cell culture platform for                                                                                In order to reduce cost and shorten timelines engineering       structural characterisation of the (glyco)protein. For
                                                                    • The MHRA’s view on QbD
     CHO cell line generation and therapeutic                                                                                    efforts have to be reduced as much as possible. In this         biosimilars, this can be performed initially to determine
                                                                    • Feedback on recent submissions to the agency
                                                                                                                                 presentation, we focus on mAb processes as a major              the expected sequence of the target molecule, then to
     protein production at large-scale                              • Advice for industry                                        product class from the biopharmaceutical industry.              confirm the structure of the biosimilar and finally
     Dr John Fann, Senior Group Manager, Cell Culture,                    Dr Keith Chidwick,                                     A study will introduce our process platform concepts
     Abbott Laboratories, USA                                                                                                                                                                    to provide comparative data side-by-side with the
                                                                          Senior Pharmaceutical Assessor,                        “Process4Success” integrating single-use equipment              originator as required by various regulatory guidelines.
     15.40                                                                MHRA, UK                                               for an existing building and for a greenfield facility.
                                                                                                                                                                                                 Dr Fiona M Greer, Global Director, Biopharma
     Solutions for efficient manufacturing processes                15.40                                                        Dr Thorsten Peuker, Vice President, Integrated                  Services Development, SGS M-Scan, UK
     There is increasing pressure on the industry to reduce                                                                      Solutions, Sartorius Stedim Biotech, Germany
                                                                    Discussion Panel - QbD                                                                                                       15.40
     costs and time to market whilst still meeting the stringent    • When should companies start implementing a                 15.40
     cGMP standards for high quality of the end product.              QbD strategy?
                                                                                                                                                                                                 Industrialisation of in-process analytics
                                                                                                                                 Single use bioreactors for the clinical production
     By applying Lean practices the result is a more optimised      • Setting the QTTP                                                                                                           This presentation will address: a) advantages of
     and efficient manufacturing process. Typical examples
                                                                                                                                 of monoclonal antibodies – a study to analyse                   development of in-process analytical methods
                                                                    • How do FDA requirements differ to MHRA?                    the performance of a CHO cell line and the
     of Lean benefits will be demonstrated in the handling          • What are the minimum requirements for QbD                                                                                  back-to-back with release/stability methods and
     of chromatography media and process buffers but also                                                                        quality of the produced monoclonal antibody                     b) high-throughput recovery of cell culture samples.
                                                                    • What are the next steps for QbD                            The aim of this study was to compare the performance
     through implementation of ready to use products.               • Can QbD used to fail products?                                                                                             Dr Robert van den Heuvel, Director, Process and
                                                                                                                                 of one CHO cell line in a SUB with its performance in a
     Dr Joakim Lundkvist, BioProcess Modality Manager,              Dr Keith Chidwick, Senior Pharmaceutical Assessor,                                                                           Protein Characterisation, MSD, The Netherlands
                                                                                                                                 traditional stainless steel bioreactor (SSB). The study was
     GE Healthcare Life Sciences, Sweden                            MHRA, UK                                                     performed on a 250 L scale in a GMP environment. Same           16.15
     16.15                                                          Dr Barbara Rellahan, FDA, USA                                media lots were used and the corresponding bioreactors          Afternoon Tea and Poster/Exhibition
     Afternoon Tea and Poster/Exhibition                            Dr James Blackwell, Senior Consultant,                       were inoculated from the same preculture campaign.              Viewing Time
     Viewing Time                                                   BioProcess Technology Consultants, USA                       Dr Sonja Diekmann, Manager, Fermentation
                                                                    16.15                                                        Development, Roche Diagnostics, Germany                         JOIN US FOR HIGH SPEED NETWORKING
     JOIN US FOR HIGH SPEED NETWORKING                                                                                                                                                           (SEE PAGE 2 FOR FURTHER INFORMATION)
     (SEE PAGE 2 FOR FURTHER INFORMATION)                           Afternoon Tea and Poster/Exhibition                          16.15
                                                                    Viewing Time                                                 Afternoon Tea and Poster/Exhibition                             16.50
     16.50                                                                                                                       Viewing Time                                                    Specific challenges and solutions for the
                                                                    JOIN US FOR HIGH SPEED NETWORKING
     Latest update on the role of RNAi to                                                                                                                                                        manufacturing of recombinant proteins
                                                                    (SEE PAGE 2 FOR FURTHER INFORMATION)                         JOIN US FOR HIGH SPEED NETWORKING
     optimise bioprocessing and reduce costs                                                                                                                                                     from microbial systems
     RNA interference is being applied in bioprocessing to          16.50                                                        (SEE PAGE 2 FOR FURTHER INFORMATION)                            (see www.bio-production.com for more information)
     optimise and improve monoclonal antibody production.           QbD on a budget – how can small companies                                                                                    Dr Wolfgang Walcher, Head, DSP, Sandoz, Austria
                                                                                                                                 16.50
     Using this approach, all cellular pathways can be targeted     implement a QbD process in line with
     (e.g. apoptosis, metabolism, and glycosylation) individually                                                                Preview of the PDA’s New Technical Report
                                                                    international regulations?                                   on Single Use Systems
     or in combinations with potent small interfering RNAs
                                                                    QbD is a “voluntary” regulatory initiative that requires
     (siRNAs) that can affect cell growth and protein quality.
                                                                    some investment and time to implement, but the
                                                                                                                                 The promise of SUS is cheaper, faster and more reliable,
                                                                                                                                 but equally important are achieving product quality,
                                                                                                                                                                                                   I particularly like the
     Dr Anthony Rossomando, Senior Director,                        return on benefits can be significant, even for small
     Alnylam Biotherapeutics, USA                                   companies, especially when combined with business
                                                                                                                                 ensuring patient safety and meeting regulatory compliance.
                                                                                                                                 Additional to those important areas, the Technical Report
                                                                                                                                                                                                   additional sessions on
                                                                    systems to drive efficiency of program execution and
                                                                    time to market. This talk will provide a roadmap for         also describe a broad range of technical options as well as
                                                                                                                                 discussing stakeholder management and other business or
                                                                                                                                                                                                   biosimilars, formulation
                                                                    implementation of QbD and provide estimates of
                                                                    minimal investments required.                                practical considerations in a SUS implementation project.         and novel products
                                                                    Dr James Blackwell, Senior Consultant,                       Dr Morten Munk, Vice President, BD and Technology
                                                                    BioProcess Technology Consultants, USA                       Specialist, CMC Biologics, Co-Chair of PDA Task Force             Dr Alahari Arunakumari, President,
                                                                                                                                 for Single Use Systems, Denmark                                   AHA Bioconsultants, USA


     17.30
     Inspirational speaker
     In 1982 the Sir Galahad was destroyed in Bluff Cove on the Falkland Islands. On board was a Welsh Guardsman, who suffered extensive burns covering 46% of his body. Following his injuries and over 70 operations, his road to physical, spiritual
     and mental recovery saw him active in a number of highly successful ventures. His charitable work earned him an OBE in the 1992 Queen's Birthday Honours and was also awarded the Freedom of the City of Liverpool in 2002 in recognition of
     his bravery and his charity work in the region and in 2009 he was appointed President of Wales Scouting. His story is one of achievement, of triumph over adversity, of seizing the moment and succeeding.
            Simon Weston, OBE,
            Falklands Hero and
            Motivational Speaker
     18.15
     Book Signing, Drinks Reception and Networking Dinner



    DAY TWO - THURSDAY 20 OCTOBER 2011
     Avoiding Bottlenecks;                                          Preparing for the                                            Implementing Flexible,                                          High-Throughput
     New Downstream                                                 Impending ICH Q11                                            Modular Disposable                                              Analytical Methods for
     Technologies                                                   Guideline                                                    Facilities                                                      Improving Bioprocessing
     08.00                                                          08.00                                                        08.00                                                           08.00
     Morning Coffee + Free Training Course on                       Morning Coffee + Free Training Course on                     Morning Coffee + Free Training Course on                        Morning Coffee + Free Training Course on
     Managing a Team                                                Managing a Team                                              Managing a Team                                                 Managing a Team
     09.00                                                          09.00                                                        09.00                                                           09.00
     Chairperson’s Opening Remarks                                  Chairperson’s Opening Remarks                                Chairperson’s Opening Remarks                                   Chairperson’s Opening Remarks
     By attending this session you will:                            By attending this session you will:                          By attending this session you will:                             By attending this session you will:
     • Overcome bottlenecks during upstream/downstream              • Gain unique insight into the impending ICH Q11             • Discover the latest disposable technologies driving           • Effectively characterise your biotherapeutic to
       processing                                                     Guideline                                                    modern facilities                                               improve bioprocessing
     • Discover the future downstream technologies driving          • Evaluate your next move following the FDA Process          • Evaluate the potential cost savings by moving to              • Evaluate non-invasive technologies to monitor
       down the cost of bioproduction                                 Validation Guideline                                         continuous manufacturing                                        extractables and leachables
     • Evaluate cheaper alternatives to Protein A                   • See how other companies are interpreting the guidance                                                                      • Discover pre-formulation strategies for mAbs
                                                                                                                                 09.05
     09.05                                                          09.05                                                        New concept for modern design of modular                        09.05
     Downstream process development                                 An industry perspective of the impending                     vaccine facilities                                              Glycosylation analysis of immunoglobulin G:
     adaptation to upstream changes                                 ICH Q11 Guideline?                                           This presentation will look at how the industry can             Biopharmaceutical and clinical applications
     Whilst improving cell growth and viral productivity in         • What is the thinking behind ICH Q11?                       dramatically reduce time and cost of new vaccine
                                                                                                                                                                                                 In collaboration with Hoffmann-La Roche, we developed
     USP, DSP may become the production bottleneck if               • What are the current discussions and regulatory            facilities by applying standardisation, modular design
                                                                                                                                                                                                 MALDI-MS as well as fast LC-ESI-MS methods for the
     not able to withstand changes. This presentation will            expectations?                                              and single-use technology. There is global need for
                                                                                                                                                                                                 characterisation of IgG Fc glycosylation at the tryptic
     discuss two case studies that appeared during cell                                                                          more affordable vaccines, and this new concept for
                                                                    • What will companies have to change following the                                                                           glycopeptide level. High throughput is achieved
     culture optimisation of a viral vaccine candidate.                                                                          design vaccine facilities shows that it is possible to
                                                                      ICH Q11                                                                                                                    through a largely robotised workflow together with
                                                                                                                                 lower the cost by 40-60% and the project time
     Dr Virgine Fabre, Head of Purification Unit, Bioprocess        Brian Withers, ICH Q11 Rapporteur, Abbott, UK                                                                                automatic measurement and data processing. Methods
                                                                                                                                 to 8-12 month. A case study will be presented.
     R&D, Downstream Process, sanofi pasteur, France                                                                                                                                             are applied to characterise recombinant IgG as well as
                                                                                                                                 Dr Klaus Hermansen, Senior Specialist, Consulting,
                                                                    09.40                                                                                                                        antibodies from patient sera for biomarker discovery
     09.40                                                                                                                       NNE Pharmaplan, Denmark, plus end-user
     The future of downstream processing:                           Discussion Panel -                                                                                                           Dr Maurice Selman, Analytical Chemist and Mass
                                                                    How are companies preparing for the                          09.40                                                           Spectrometrist, Leiden University Medical Center,
     Alternative technologies                                                                                                    Single-use mixing solutions for large-scale                     The Netherlands
                                                                    impending ICH Q11 guideline?
     Downstream processing is becoming more and more                                                                             media and buffer preparations and
     challenging since very high product titres were achieved.      • Practical considerations of the impending ICH Q11                                                                          09.40
                                                                      guideline?                                                 downstream unit operations
     Innovative techniques like precipitation, crystallisation                                                                   This presentation focuses on case studies using large volume    Deploying high-resolution analytics to
     and aqueous-two-phase extraction might complete or             • How will companies think following ICH Q11                                                                                 regulatory compliant laboratories
                                                                                                                                 single-use mixing technology. Scalability of buffer and media
     even replace certain conventional purification steps.          • Interpreting the latest guidelines; knock on effects       preparations from 50L to 2,500L is first demonstrated           Dr Patrick Boyce, Biopharmaceutical Marketing
     Together with the demand for short development                 • What will companies have to change following the           using a magnetically-driven mixing technology. A simulation     Manager, Europe & India, Waters, UK
     timelines a major challenge arises to develop safe,              ICH Q11                                                    of a low pH virus inactivation is then presented using a
     robust and also highly economic downstream                     • What reservations do companies have on this guideline?     contactless levitated impeller technology and a single use      10.15
     processes in the light of high titer.                                                                                       pH sensor. Finally, an example of final formulation is          Morning Coffee and Poster/Exhibition
                                                                    10.15                                                        discussed with the re-suspension of a vaccine adjuvant.         Viewing Time
            Dr Dorothee Ambrosius,
            Senior Vice President, Process Science,                 Morning Coffee and Poster/Exhibition                         Dr Jean-Marc Cappia, Group Vice President, Marketing and
            Boehringer Ingelheim, Germany                           Viewing Time                                                 Product Management, Sartorius Stedim Biotech, France
     10.15                                                                                                                       10.15
     Morning Coffee and Poster/Exhibition                                                                                        Morning Coffee and Poster/Exhibition
     Viewing Time                                                                                                                Viewing Time



4                                                                           To Register Please Tel: +44 (0)20 7017 7481 Fax: +44 (0)20 7017 7823
   Non-Protein A Capture,                                          Process Validation, QbD                                         Continuous, Green and                                         Aggregation, Formulation
   Automation and Bi-Specifics                                     and PAT                                                         Cell-Free Manufacturing                                       and Cell Therapies
   11.00
   Scaling-up of a downstream purification                             FDA Process Validation Guideline -                           What Role Will Continuous                                     Controlling Aggregation,
   process for a new recombinant product (rhFVIII)                     Requirements and Interpretations?                            Manufacturing Play in BioProduction?                          Extractables and Leachables
   Octapharma has developed a new process for the
   production of a recombinant human FVIII product                 11.00                                                           11.00                                                         11.00
   derived from a human cell line (HEK293F cells).                 What are the main drivers behind the                            Advanced manufacturing strategies                             Controlling aggregation in pre-filled
   This presentation will discuss scale-up of a new                FDA Process Validation Guideline and                            continuous versus fed batch                                   syringes and new non-invasive technologies
   downstream purification process and also different              how should industry adopt it?                                   What are the optimum batch manufacturing approaches           for monitoring extractables and leachables
   purification alternatives that have been applied                •   Why was the Guideline updated in the first place?           and how do these compare with the development of              The talk will present new methods to study and quantify
   during the pre-clinical and clinical phase.                     •   Who will be impacted by the guideline?                      operations that support continuous operation? Here            sub-visible and visible protein aggregates and leachables in
   Dr Martin Linhult, Team Manager Pilot Plant,                    •   What are the new expectations?                              we examine these questions, using the latest process          pre-filled syringes and vials using laser beams and digital
   Octapharma, Sweden                                              •   What key themes are the FDA recommending?                   modelling approaches based on commercially available          scanning and recording of particle images. The methods
                                                                   •   How will this impact Europe?                                technologies looking at the impact of scale, flexibility      are non-invasive and can be used in pharmaceutical research
   11.35                                                                  Dr Gert Mølgaard,                                        looking for the first time at implications of continuous      and development as well as in the in-line automatic control
   Development of a non-protein A mAb                                     VP, Strategic Development,                               downstream and disposable technologies.                       during the manufacturing of pre-filled dosage forms.
   capture step based on selective                                        NNE Pharmaplan, Denmark                                  Dr Andrew Sinclair, Managing Director,                        Professor Tudor Arvinte, Chairman, CEO,
   precipitation combined with CEX                                                                                                 Biopharm Services, UK                                         Therapeomic Inc., School of Pharmacy,
                                                                   11.35                                                                                                                         University of Geneva, Switzerland
   We developed a process which uses selective precipitation
   combined with a novel cation exchange (CEX) resin               Industry’s reaction to the FDA Process                          11.35
   as the initial purification step. Several CEX resins were       Validation Guideline                                            Applying batch manufacturing technologies                      Preformulation as a key step in
   evaluated for binding capacity, selectivity and cleanability.   • How will companies implement the changes?                     to continuous downstream processing                            Product Development
   The selected CEX resin had a significant increased              • How will the guideline be filtered down to other              Professor Alois Jungbauer, Department of
   capacity over protein A and data indicate a purity                parts of company?                                             Biotechnology, University of Natural Resources                11.35
   which is nearly equal to a typical protein A eluate.            • Is it a good thing for the industry?                          and Life Sciences Vienna, Austria                             Preformulation is a key step in
   The initial data show that the combined use of                  • Does Europe’s approach differ to the FDA’s?                                                                                 biotherapeutics formulation development
   selective precipitation and CEX are promising for future        • How will interaction change between development               12.10
                                                                                                                                                                                                 This presentation will look at: Developability and risk
   ‘high titer’ antibody purification processes.                     and GMP?                                                      Continuous biochromatography for highly                       assessment on lead candidates; In-depth understanding
   Dr Daniëlle van Wijk, DSP Specialist, Synthon B.V,              • Why not “three batch” validation- how do we know              productive polish steps: Case studies with                    of major critical properties and degradation pathways;
   The Netherlands                                                   what to do?                                                   HIC, SEC and RPfornon-mAb proteins                            Anticipation of candidates’ behaviours under relevant
                                                                   Dr Siegfried Schmitt, PDA Task Force Member,                    Continuous chromatography has been successfully               stresses; Design of scientifically sounding formulation
   12.10                                                           Consultant, Parexel, UK                                         applied in the large-scale production of chemical             screenings; mAbs case studies will be presented to
   Highly sensitive PCR-based assays:                                                                                              APIs for two decades i.e. the so-called SMB-process.          evidence some of these approaches.
                                                                   12.10
   Rapid detection of cell culture contamination                                                                                   In the case studies presented here, the application and       Dr Otmane Boussif, Director, BioProcess R&D,
                                                                   Discussion Panel - Process Validation
   We have recently developed Real-Time PCR based                  • Is it a good thing for the industry?                          process development for a HIC, a SEC and a RP polish          Sanofi Pasteur, France
   assays that allow for rapid, highly sensitive detection of                                                                      step run in continuous mode is shown for non-mAb
                                                                   • Will it involve more cost, or save money?                                                                                   12.10
   mycoplasma, Mouse Minute Virus (MMV) and vesivirus                                                                              proteins and the benefit versus batch chromatography
                                                                   • Will it prevent lot failures by forcing companies to                                                                        Spotlight Presentation
   2117. We will review the assay designs, sensitivity,              know more about their process                                 in terms of purity, yield, throughput and buffer
   sample preparation and proprietary discriminatory                                                                               consumption is demonstrated.                                  These sessions are hosted by leading companies who
                                                                   • Increased documentation/SOPs                                                                                                operate in the field of bioproduction and offer an
   positive/extraction controls developed for these assays                                                                         Professor Massimo Morbidelli, Institute for Chemical
                                                                   • How to manage variation during process validation                                                                           opportunity to learn about the latest developments and
   during our presentation.                                                                                                        and Bioengineering, ETH Zurich, Switzerland
                                                                   Dr Peter Watler, CTO, Hyde Engineering +                                                                                      technological advancements in the industry. If you would
   Dr Michael T. Brewer, Senior Manager, Technical                 Consulting, USA
   Marketing, Life Technologies Inc., USA                                                                                          12.45                                                         like to host a spotlight presentation please contact
                                                                   Dr Siegfried Schmitt, PDA Task Force Member,                    Lunch and Poster/Exhibition Viewing Time                      james.miguel@informa.com or Tel: +44 (0) 207 017 5011
   12.45                                                           Consultant, Parexel, UK
                                                                   Dr Gert Mølgaard, VP, Strategic Development,                                                                                  12.45
   Lunch and Poster/Exhibition Viewing Time
                                                                   NNE Pharmaplan, Denmark                                          Environmental Assessment                                     Lunch and Poster/Exhibition Viewing Time
   14.00                                                           Dr Morten Munk, Vice President, BD and Technology                of Biomanufacturing                                          By attending this session you will:
   High throughput process development –                           Specialist, CMC Biologics, Co-Chair of PDA Task                                                                               • Find new methods to control protein aggregation
   Integration of screening, rapid analytics                       Force for Single Use Systems, Denmark                           By attending this session you will:                             and improve stability
   and model based development                                                                                                     • Develop more environmentally-friendly                       • Gain unique insight into Novartis’ approach to
                                                                   12.45                                                             manufacturing processes
   In the downstream area of biopharmaceutical production,                                                                                                                                         personalised medicine
   the demand for fast process development with limited            Lunch and Poster/Exhibition Viewing Time                        • Gain insight into the growing antibody fragment market      • Evaluate the market opportunities in cell-based therapies
   material is everyday life. We will present an example for                                                                       • Find exciting new expression platforms for novel products
   the optimisation of an ion exchange chromatographic                 Case Studies on Implementing                                                                                              14.00
   multi-component separation performed on a robotic                   Process Validation, QbD and PAT                             14.00                                                         Protein improvement by rational design
   platform, combining rapid and designed experimentation                                                                          Eco-lateral impact of biopharmaceutical                       When proteins are employed as therapeutics they need
   with ‘in-silico’ model based processing of data.                By attending this session you will:                             manufacturing                                                 to withstand conditions that evolution has not prepared
           Professor Jürgen Hubbuch,                               • See how companies are implementing QbD                        In this study a complete life cycle analysis of               them for, such as high concentrations, the absence of
                                                                   • Apply QbD to unique therapies such as ADCs                    biopharmaceutical manufacturing was performed.                molecular chaperones, air-water interfaces and shearing
           Professor, Karlsruher Institut für
                                                                   • Successfully implement PAT to reduce variability              It started from raw material manufacturing to                 forces. We argue that the only reliable manner to adapt
           Technologie (KIT), Germany
                                                                                                                                   drug product distribution to affiliate countries.             the protein to these non-native challenges is to alter its
                                                                   14.00                                                           The main contributors to the environmental impact             amino acid sequence. Our experience shows that single
    Manufacturing Bi-Specifics and                                 What does it takes to make an analytical                        of biopharmaceutical manufacturing are identified             point mutations selected by rational means can have
    Antibody Mixtures                                              lab ready for QbD? - Are you ready for                          and solutions to reduce it are discussed.                     dramatic beneficial effects.
                                                                   QbD process validation?                                                                                                       Professor Joost Schymkowitz,
                                                                                                                                   Dr Henri Komman, Director, Biotech Production,                VIB Switch Laboratory, Belgium
   By attending this session you will:                             This talk will focus on challenges that were faced and          Merck Serono, Switzerland
   • Understand the unique manufacturing challenges                tackled by the analytical laboratory to provide broader
     facing bi-specifics and antibody mixtures                     quality tools, gain speed and efficiency, while keeping                                                                        The Era of Personalised Medicine
   • Partner with cutting-edge companies: Genmab,                  very high precision standards.                                   Overcome the Unique Manufacturing
     Merus, Symphogen and NovImmune                                Dr Gianni Beer, Senior Manager, Biotech Process                  Challenges of Antibody Fragments                             14.35
                                                                   Sciences Analytics, Merck Serono, Switzerland                                                                                 FEATURED PRESENTATION
   14.35                                                                                                                           14.35                                                         Delivering the final market image in the era
                                                                   14.35
   Development of a manufacturing platform                                                                                         Optimising the production of antibody                         of personalised medicine

   the κλ-body
   for a unique next generation antibody,                          ImmunoGen’s approach to conjugate                                                                                             This presentation will look at the following issues:
                                                                   production processes                                            fragments (tbc)
                                                                                                                                                                                                 Starting with the right drug substance; Leveraging
                                                                   ImmunoGen develops conjugates incorporating one                 (see www.bio-production.com for more information)
                                                                                                                                                                                                 formulation platforms but accommodating non-platforms
   NovImmune has developed a novel therapeutic antibody            of its proprietary derivatives of the cytotoxic agent           Dr David Humphreys, Director, Antibody Biology,               in pharmaceutical development; Combination product
   format that is indistinguishable from a standard IgG.           maytansine attached to tumor-targeting antibodies.              UCB, UK                                                       influence on pharmaceutical development including
   The talk will address the challenges in developing a            A case study is presented on the development using                                                                            final configurations (devices, ADCs, drug mixtures);
   antibody format, the κλ-body.
   platform manufacturing process for this novel bispecific                                                                        15.10
                                                                   QbD for a conjugation process that consistently                                                                               QbD considerations for drug product
                                                                   achieves the necessary product attributes.                      Fab-Fv - An antibody fragment format with
                                                                                                                                                                                                         Dr Sheryl Martin-Moe,
   Dr Nicolas Fouque, Section Head, Process Development            Dr Deborah Meshulam, Director, Process Science                  extended serum half-life
                                                                                                                                                                                                         Global Head Biologics, Pharmaceutical
   and Bulk Manufacture, NovImmune, Switzerland                    and Engineering, Immunogen, USA                                 (see www.bio-production.com for more information)                     Development, Novartis, Switzerland
                                                                                                                                   Dr Sam Heywood, Principal Scientist, UCB, UK
   15.10                                                           15.10                                                                                                                         15.10
   Development of a production process for                         Taking QbD from concept to reality                              15.45                                                         “Breaking News” Slot
   Duobody: novel human bispecific platform                        This presentation will show companies how to reach QbD          Afternoon Tea and Poster/Exhibition                           As the conference agenda is finalised 6 months prior to
   Bispecific antibodies show great promise for the                goals such as: Reduced batch-failure rates, reduced             Viewing Time                                                  the event we are reserving one slot for a presentation
   durable treatment of many different diseases in the             final-product testing, lower batch-release costs; faster        16.20                                                         addressing the most recent developments in
   area of oncology, inflammation and infectious diseases.         regulatory approval of new product applications, fewer                                                                        bioproduction. If you have some newly published data
                                                                   inspections of manufacturing sites, more predictable            FEATURED PRESENTATION
   This presentation will describe how Duobody molecules                                                                                                                                         that you would like to present in this slot please contact
                                                                   supply of product and faster process changes.                   Emergence of low-cost open cell-free protein                  daniel.barry@informa.com tel: +44 (0) 207 017 6978 to
   are generated at small scale and how this process is
   translated to manufacturing at larger scale.                    Dr Randy Tatlock, Manager of Customer Development,              synthesis as a viable route to design and                     submit your abstract for approval by the advisory board.
                                                                   Aegis Analytical Corporation, USA                               manufacturing of novel protein therapeutics
   Dr Patrick van Berkel, VP, Global CMC R&D,                                                                                                                                                    15.45
                                                                                                                                   Sutro has developed a scalable cell–free protein
   Genmab, The Netherlands                                         15.45                                                                                                                         Afternoon Tea and Poster/Exhibition
                                                                                                                                   synthesis system for the efficient production of
                                                                   Afternoon Tea and Poster/Exhibition                             therapeutic proteins. The platform is a powerful              Viewing Time
   15.45
                                                                   Viewing Time                                                    protein design tool in that many variants of potential
   Afternoon Tea and Poster/Exhibition
   Viewing Time                                                    16.20                                                           protein therapeutics can be made at research scale in          Manufacturing Cell Therapies
                                                                   Implementation of PAT system in bioprocess                      a rapid parallel manner in several hours. This approach
   16.20                                                           development, scale up and process transfer                      combines the power of protein engineering with                16.20
   Production of Antibody mixtures and                                                                                             unique chemistries, greatly expanding the functional          Taking regenerative medicine therapies
                                                                   This presentation will show the comparison of results           chemical diversity space for design of novel therapeutic
   bispecific IgGs from single clonal cells                        gained using on-line and off-line analytical equipment                                                                        from clinical research to commercial
   A demonstration of adequate production levels, cell line                                                                        proteins, and the platform can be scaled for rapid            products: Challenges and approaches
                                                                   and procedures. Based on these results, the potential
   stability and analytical tools to characterise antibody                                                                         production to support clinical studies and provide            (see www.bio-production.com for more information)
                                                                   applicability of the PAT system in process development,
   mixtures is provided as well as a chromatographic                                                                               a viable manufacturing route.                                 Dr Christian van den Bos, Executive Programme
                                                                   scale up, process transfer, characterisation and
   separation approach to purify bispecific IgGs.                  troubleshooting will be discussed. A systematic approach               Dr Trevor Hallam,                                      Manager, Lonza, UK
   Dr Lex Bakker, Chief Development Officer, Merus BV,             to reduce and control process variability during the scale up          Chief Scientific Officer,
                                                                   and transfer using the PAT system will also be presented.              Sutro Biopharma, USA                                   16.55
   The Netherlands
                                                                   Dr Saša Stojković, Head, Pilot Bioprocess                                                                                     Development of a novel VLP vaccine
   16.55                                                                                                                           16.55                                                         delivery system in yeast
                                                                   Development, Sandoz, Slovenia
   Can you manufacture recombinant antibody                                                                                        Drug-like properties of Anticalins: A next                    Hepatitis B core protein readily forms virus like particles
   mixtures of superior efficacy in a robust and                   16.55                                                           generation therapeutic protein drug platform                  (VLP) and is well known to be capable of delivering third
   economically feasible way?                                      Increased bioprocess understanding based                        (see www.bio-production.com for more information)             party antigens in a highly immunogenic context. We initially
                                                                   on advanced on- and off-line process                            Dr Thomas Sandal, VP, Bioprocess and CMC,                     expressed our chimeric proteins in E-coli and successfully
   Symphogen has developed a technology where multiple
                                                                   monitoring platform in combination with                         Pieris AG, Germany                                            developed a downstream process. However, bacterial
   antibodies are produced in a single-batch process, thus
   reducing CMC developmental costs to levels similar to
                                                                   chemometrics - the starting point for QbD                                                                                     contaminants were such that the system had to be
                                                                   (see www.bio-production.com for more information)               17.30                                                         redeveloped for expression in the yeast Pichia pastoris.
   those of mAbs.                                                                                                                  End of BioProduction;                                         We will present data showing that immunogenic VLP
                                                                   Dr Gerald Striedner, Austrian Centre of
   Dr Anne Bondgaard, Director, Antibody Expression,               Biopharmaceutical Technology, University of Natural             Registration for Post-Conference Workshops                    can now be successfully recovered using this approach.
   Symphogen, Denmark                                              Resources and Applied Life Sciences, Austria                    (see page 6 for further info)                                 Dr Mike Whelan, Head of R&D, iQur, UK
   17.30                                                           17.30                                                                                                                         17.30
   End of BioProduction;                                           End of BioProduction;                                                                                                         End of BioProduction;
   Registration for Post-Conference Workshops                      Registration for Post-Conference Workshops                                                                                    Registration for Post-Conference Workshops
   (see page 6 for further info)                                   (see page 6 for further info)                                                                                                 (see page 6 for further info)



Email: registrations@informa-ls.com Web: www.bio-production.com Please quote: CQ3446                                                                                                                                                                            5
                                                                                                                WORKSHOPS + SEMINARS
19-20 October 2011, Maritim proArte Hotel, Berlin, Germany
                                                                                                                                           Save £200
Pre-Conference Workshops – Tuesday 18 October 2011                                                                                       by Attending a
Start: 10:00 • End: 16:00 • Lunch and Morning Refreshments will be included • Visit website for free samples of workshop documentation   Pre- and Post-
                                                                                                                                           Workshop!
  Comparability: Developing                             Implementation of Quality by                              Product Characterisation
  Strategies for Scaling Up                             Design (QbD) for Biopharmaceuticals                       of Biopharmaceuticals for
  and Other Process Changes                             Workshop V                                                Regulatory Requirements
  Workshop U                                                                Introduction                                                            Workshop W
  Introduction                                                              This full-day workshop concerns the theory and practice                 Topics to be covered:
  The objective of this workshop is to provide principles                   for implementation of Quality by Design (QbD) systems                   • Product characterisation in general – for products
  for assessing the comparability of biological products,                   for biopharmaceuticals. The emphasis will be on QbD                       including recombinant proteins, glycoproteins,
  to discuss approaches to demonstrate comparability                        to support drug design and manufacturing as well as                       antibodies, and vaccines
  and to review regulatory requirements.                                    biopharmaceutical comparability.
                                                                                                                                                    • What characterisation should be performed and when?
  • ICH Q5E                                                                 Topics to be covered:                                                   • Mass Spectrometry and other physicochemical
  • The importance of Scientific Advice at the national                     • Regulatory and commercial drivers for QbD                               analytical techniques – pros and cons of specific
    and EMA level                                                           • Key principles of a QbD framework, Design Space                         techniques
  • When a CMC comparability exercise does not suffice:                       (DS), Control Spaces, Critical Quality Attributes (CQAs)              • Protein and carbohydrate structure analysis including
    Non-clinical and clinical testing                                       • GTO-QbD - a simple, elegant and practical framework                     co- and post-translational modifications, aggregation
                                                                                                                                                      and fragmentation
  • Case Studies to illustrate various process changes and                    for QbD for biologics
                                                                                                                                                    • Glycosylation analysis strategies
    their impact                                                            • Determining CQAs - a key step to implementing QbD
                                                                                                                                                    • ICH Guidelines and other regulations
  • Post marketing authorisation manufacturing process                      • Expanding your product design space with clinical data
    changes: variations                                                                                                                             • Analytical and problem solving case studies
                                                                            • Determining profiles to measure the CQAs for your
  Workshop leaders:
                                                                              therapeutic                                                           Workshop leaders:
                                                                            • Using Process Analytical Technology (PAT) to reduce                   Dr Andrew Reason, Managing Director,
  Mr Robert Blakie, Director of Regulatory Affairs
                                                                              risk and waste in a QbD based manufacturing system                    SGS M-Scan Ltd, UK & M-Scan GmbH, Germany
  and General Manager, ERA Consulting Group, UK
                                                                            • Case study                                                            Dr Fiona Greer, Global Director, Biopharma Services
  Dr Alex Bloom, Regulatory Affairs Project Manager,                                                                                                Development, SGS M-Scan, UK
  ERA Consulting Group, UK                                                  Workshop leader:
                                                                            Dr Daryl Fernandes, Founder and CEO, Ludger, UK                         Stimulating workshop with excellent
                                                                                                                                                    content and knowledgable presenters
                                                                                                                                                    Principal Scientist, GSK, Workshop Attendee 2010



Post-Conference Workshops – Friday 21 October 2011
Start: 09:00 • End: 15:00 • Lunch and Morning Refreshments will be included

  From Development to Market -                                              Understanding Aggregation and                                           Single Use vs. Stainless Steel:
  Biosimilar Monoclonal Antibodies                                          Devising Prevention Strategies                                          Impact on Design of Flexible
  in the EU and US                                                          Workshop Y                                                              Modular-Based Facilities
  Workshop X                                                                Introduction                                                            Workshop Z
  Introduction                                                              Attend this full-day workshop to gain a critical overview               Introduction
                                                                            of the available techniques for detection of aggregation                The workshop will address the issues and opportunities
  Monoclonal antibodies have been established as important
  therapeutics in cancer and autoimmune diseases. Drugs                     and how these methods can be applied across bioprocessing.              offered by current state of the art disposable technologies.
  such as Infliximab, Bevacizumab, Rituximab, Adalimumab,                   Topics to be covered:                                                   In today’s environment we are looking for facilities where
  and Trastuzumab are worldwide among the top selling                                                                                               the initial capital investment is lower and the build is
  therapeutic proteins. This workshop will help to develop an               In addition, delegates will hear about strategies for
                                                                            combining analytical methods to ensure detection across                 quicker and at the same time provides a facility that
  expert understanding of biosimilar and next-generation                                                                                            is cost effective and flexible.
  monoclonal antibodies, including development                              a range of particle sizes. There will be a chance to review
  requirements, strategies, costs, and timelines.                           what is understood about the triggers of aggregation and                Topics to be covered:
                                                                            the progress made in engineering products to reduce the                 In this workshop we will be focusing on how single
  Topics to be covered:                                                     risk of aggregation.                                                    use technologies can simplify design and look in some
  •   Prepare a development plan                                            • A critical overview of the applications of the                        detail at where they add value and more importantly
  •   Define a target product profile                                          following technologies:                                              look at where they do not. This will be illustrated using
  •   Lay out an analytical strategy and plan                               • Reverse phase chromatography                                          some practical case studies and we have invited end
                                                                            • Dynamic light scattering                                              users to discuss the reality that lies behind the rhetoric.
  •   Select an appropriate cell line and manufacturing platform
                                                                            • Size exclusion chromatography                                         The workshop will also give special consideration
  •   Evaluate biosimilarity, and to evaluate the value of                                                                                          to the challenges and opportunities within vaccine
      non-clinical studies                                                  • Field flow fractionation                                              manufacture, the requirements to support clinical
  •   Plan and execute clinical studies                                     • Using biophysical analysis to identify potential causes               material supplies and review the limitations imposed by
  •   Apply for extrapolation of indications                                   of aggregation                                                       scale (how big can disposables go). In addition we will
  •   Use data from global sourced reference products                       • Examining the latest new techniques in development                    examine the issues that surround Biosafety BL2 and BL3
  •   Design a pharmacovigilance plan and post-authorisation                   - Fluorescent dyes for characterising protein aggregates             facilities and the implications for single use systems.
      follow-up                                                                - The use of NanoSight to detect submicron aggregates
                                                                                 compared to DLS                                                    Workshop leaders:
  Workshop leader:                                                                                                                                  Dr Klaus Hermansen, Senior Specialist,
  Dr Carsten Brockmeyer, Biosimilar Expert & Managing                       Workshop leaders:                                                       nme Pharmaplan, Denmark
  Director, Brockmeyer Biopharma, Germany                                   Professor Tudor Arvinte, Chairman and CEO,                              Dr Andrew Sinclair, Managing Director,
                                                                            Therapeomic Inc and School of Pharmacy,                                 Biopharm Services, UK
                                                                            University of Geneva, Switzerland
                                                                            Dr Martinus Capelle, Senior Scientist and Project
                                                                            Manager, Therapeomic Inc, Switzerland.


SME Licensing and Partnering Workshop - Day One at 9.00am                                                       Improve your Team Management Skills by Attending
Are you looking to license out a new technology or product? If so join this 2 hour practical Workshop to        our Free Training Seminar on the Morning of Day 2
find out the critical regulatory, licensing and outsourcing options available to you - FREE for all delegates   Successful businesses rely on managers that attract, develop, motivate and retain the best people.
Key topics covered include:                                                                                     This breakfast session will show you how to effectively manage a team in order to achieve key
• What big pharma are looking for in a product/ company?                                                        company goals, another reason to attend BioProduction 2011.
• When is the best time to do a deal?
• What qualities are big pharma looking for in an SME company and its products?
• How does big pharma set a value on products and companies?
• When should companies outsource, why and when?
• The legal framework
Led by:
Dr David Scott, Licensing Expert, Pharma Consulting, UK
Dr Lincoln Tsang, Partner, Arnold and Porter LLP, UK
This interactive, open session will run from 9.00 until 11.00 on Wednesday 19 April, concurrent to
the plenary session. It is free for all participants, however, priority will go to SME companies and
academic groups.




                                                               To Register Please Tel: +44 (0)20 7017 7481 Fax: +44 (0)20 7017 7823
                                                                                                                                                                O ib y r s t r s
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  REASONS TO PROMOTE YOUR BUSINESS AT BIOPRODUCTION 2011




                                                                                                                                                                         of ce !
                                                                                                                                                                            a d o
  • Meet over 250 senior level Biopharm professionals across 100+
    companies looking for new technologies and speciality services
  • Access Key Decision Makers - 35% of delegates are Director
    level or above with a million euro purchasing power
  • Meet your target market - 67% of delegates come from Europe
  • Promote your products and services to technical specialists in
    the field of Manufacturing, QbD, Upstream & Downstream
    Processing, Formulation and Analytics
  • 63% of our speaker panel are Director level or above

  Sponsor & Exhibitor Benefits
  The benefits we offer sponsors/exhibitors are designed with your business objectives in mind.
  Focusing on helping you reach ROI at our events, we aim to ensure that you return to us time
  and time again for your networking needs. We tailor specific sponsorship and exhibition packages
  to help you meet and influence the people who will ensure the growth of your business now and
  in the future. The various benefits available to your company include -
                                                                                                                                For further details about sponsorship
  • Build brand awareness with logo representation throughout the event and it's collateral                                          opportunities please contact
  • Gain a competitive edge over your rivals with a speaking slot on the main programme                                            James Miguel, Sales Director
  • Meet new clients with an exhibition stand in the main networking area                                               +44 (0)20 7017 5011 • james.miguel@informa.com


  Corporate Sponsor                                                                       Sponsors




  Associate Sponsor

                                                       Interesting speakers,
                                                       well arranged, good                        The quality of both the presentations and the
                                                       networking opportunities                   audience makes Bioproduction a must attend event
                                                       Project Manager, GE Healthcare             for Aegis Analytical Director of Marketing, Aegis Analytical


   Get the most from your conference experience...                                                          Bioproduction 2010 attendee breakdown
   WHAT PLATFORMS DO WE OFFER TO IMPROVE NETWORKING                                                                                  Geographic Region
   • 11 hours of dedicated Networking time                                                                                              Northern Europe 9%

   • Make more business contacts in 15 minutes than you can in a normal week with our
                                                                                                            Rest of World 33%                                     Western Europe 42%
     Speed Networking Facility
   • Build relationships with existing, as well as potential new customers at our
     NETWORKING DINNER at the end of day 1

   ENHANCED ONLINE PARTNERING SOLUTION...                                                                      Southern Europe 9%
                                                                                                                                       Eastern Europe 7%
   Increase the chances of you being contacted by delegates, speakers and exhibitors using
   our bespoke online partnering service. You can contact other pre registered attendees                                                Job Function
   before, during and after the event has taken place. Through this platform you can;                                                                         Senior Management / 35%
                                                                                                                  Commercial 12%
   • Upload a photograph of yourself so that delegates may recognise you during the conference                                                                Director / CEO / VP
   • Edit your company profile to help delegates understand what services / products you                     Group Leader 6%
     have to offer
   • Browse, search & Identify your key contacts
   • Suggest and set up meetings
                                                                                                                                                             Scientist / Academic 47%



   Exhibitors




     For further details about sponsorship opportunities please contact James Miguel, Sales Director, +44 207 017 5011, James.miguel@informa.com


   Over 100 companies attended Bioproduction in 2010 including
   Abbott Biologicals • ALK Abello • Amgen • Archivel Farma Sl • Ark Therapeutics • Avecia • Avid Bioservices, Inc. • Baxter Innovations GmbH • Bayer • Bayer Healthcare • Biogen Idec
   • BIOKIT S.A • BioMarin • Biomedal • BioMerieux • Boehringer Ingelheim • Bristol Myers Squibb • Centocor • Elan Pharma • Eli Lilly and Company • EMD • ETH Zurich • F. Hoffmann-
   La Roche AG • FDA • Ferring Pharmaceuticals A S • Gambro Dialysatoren GmbH • Genentech, Inc • Genzyme • GlaxoSmithKline Biologicals • Glenmark Pharmaceuticals SA •
   GlycoThera GmbH • Ipsen • Lek d d • Lonza • MedImmune • Menarini Biotech Srl • Merck Serono • Millennium Pharmaceuticals • NNE Pharmaplan A/S • Novartis • NovImmune SA
   • Novo Nordisk • Novovax • Pfizer • Pierre Fabre SA • PIERRE GUERIN SAS • Regeneron Pharmaceuticals • Rentschler Biotechnologie GmbH • RIVM • Sandoz • Sanofi Pasteur • Sanofi-
   Aventis • Sartorius Stedim Biotech GmbH • Schering Plough • Shire Pharmaceuticals • Sicor Biotech • Swedish Orphan Biovitrum AB • Swissmedic • Synthon BV • Teva Pharmaceuticals
   • Toxicon Europe • Trion Pharma GmbH • UCB • Uni Cambridge • University College London • University Kent • University of Basel • Wyeth



   Media Partners


Email: registrations@informa-ls.com Web: www.bio-production.com Please quote: CQ3446                                                                                                     7

				
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