The Williamsburg BioProcessing Foundation The Most Trusted Source of BioProcess

							                       The Williamsburg BioProcessing Foundation
                       The Most Trusted Source of BioProcess Technology®



                      Cell Engineering and Banking
                                           Optimizing Productivity, Stability and Safety
                                                      1st Annual Meeting

                                               December 4-6, 2006
                                     Washington Court Hotel - Washington, D.C.
                                                         Cell lines remain one of the most critical and variable components for
  Topics Include:                                        biopharmaceutical manufacturing. While improvements in processing tech-
                                                         niques have greatly improved productivity, the greatest gains can still be made
  • Acquisition of starting cells
                                                         by creating and selecting the best cell clones. Cell lines can also contribute
  • Cell history and traceability                        some of the most troubling safety issues for a production process, since they
  • Plasmid development and production                   have the potential for harboring adventitious agents. In far too many cases,
                                                         cells lines have not been adequately documented as to their source or the
  • Gene insertion and manipulation
                                                         materials used during initial cultivation. Without stable and properly docu-
  • Creation of immortal cell lines                      mented cell lines, product development can be delayed for years and very
  • Clone optimization and selection                     promising products may never reach clinical trials.
  • Cell expansion
                                                         Please join us for this state-of-the-art meeting on the critical issues associated
  • Media and assay development                          with developing cell banks for the production of biopharmaceuticals. We will
  • Cell bank characterization                           focus on every aspect of cell bank production, starting with the acquisition
                                                         of cells from tissues or other cell banks, and making sure the full history of
  • Cryopreservation
                                                         these cells is documented. Then, we’ll discuss the best ways to insert genetic
  • Cell bank management                                 material and select the optimal clone for production. The talks will also cover
  • Storage and stability                                the most advanced methods for characterizing the cells and freezing them for
                                                         both Master and Working Cell Banks, plus the procedures that have proved
  • Standardized cell lines and testing
                                                         most effective for managing these banks for their long-term use in product
    methods                                              manufacturing. In addition, we’ll explore the usefulness of reference or stan-
  • Reference cell lines                                 dardized cell lines, and how they might be produced.




P.O. Box 1229, Virginia Beach, Virginia 23451   •   Phone: 757.423.8823   •   Fax: 757.423.2065   •   www.wilbio.com   •   E-mail: info@wilbio.com
                             Williamsburg BioProcessing Foundation

                 Cell Engineering and Banking
                             Optimizing Productivity, Stability and Safety

                                           December 4-6, 2006

                                      First Annual Meeting
Sunday, December 3
     4:00–6:00 pm: Registration, Poster Setup, Welcome Reception — Meeting Room Foyer

Monday, December 4
      7:00–8:00 am: Registration and Continental Breakfast — Meeting Room Foyer
      8:00–8:30 am: Introduction
                    Keith L. Carson — Conference Chairman
      8:30–9:15 am: Selection and Characterization of a High-Producing Host Cell Line
                    for Influenza Vaccine Production
                    Jonathan Liu, D.V.M., Ph.D. – MedImmune Vaccines
     9:15–10:00 am: The Use of Synthetic Genetics Elements to Engineer Stable, High Producing Cell Lines
                    Igor Fisch, Ph.D. – Selexis SA
    10:00–10:30 am: Break — Meeting Room Foyer
     10:30–11:15 am: Using Lentiviral Vectors for the Rapid Development of Stable and High-Yielding Cell
                     Lines for the Production of Proteins and Vaccines
                     Boro Dropulic, Ph.D. – Lentigen Corporation
        11:15–Noon: Cell Banking in the New Millennium – Meeting the Challenges
                     Jim Moldenhauer, M.S. – Eli Lilly & Company
      Noon–1:30 pm: Lunch — Meeting Room Foyer
       1:00–1:30 pm: Poster Session
       1:30–2:15 pm: Product Testing and Banking for Cellular Therapies
                     Brenton McCright, Ph.D. – FDA HHS
       2:15–3:00 pm: Next Generation Media for Cryopreservation, Hypothermic Storage and Post-
                     Preservation Processing of Cells and Tissues
                     John Baust, Ph.D. – BioLife Solutions, Inc.
       3:00–3:30 pm: Break — Meeting Room Foyer
       3:30–4:15 pm: A Strategy to Defend Long-Term Cell Bank Stability with Data
                     Most Relevant to Manufacturing
                     Paul Duncan, Ph.D. – Merck & Company, Inc.
       4:15–5:00 pm: Cell Line Banking and Authentification
                      Jonathan Morgan, Ph.D. — ATCC
                                    Williamsburg BioProcessing Foundation

                     Cell Engineering and Banking
                                     Optimizing Productivity, Stability and Safety

                                                       December 4-6, 2006


  Tuesday, December 5
         7:30–8:30 am: American Breakfast — Meeting Room Foyer
         8:30–9:15 am: Screening and Evaluation Process to Identify a Hardy Cell Line for Use in
                       Encapsulation Cell Technology
                       Konrad Kauper – Neurotech USA
        9:15–10:00 am: How Can We Assure Cell Lines are Safe and Suitable for Production of
                       Prophylactic Vaccines?
                       Rebecca Sheets, Ph.D. – National Institutes of Health
       10:00–10:30 am: Break — Meeting Room Foyer
       10:30–11:15 am: High-Throughput Therapeutic mAb Production Line Selection Based on
                       In Situ Protein Secretion
                       Jeff Hutchins, Ph.D. – Inhibitex, Inc., and Troy Tremaine – Genetix Limited
          11:15–Noon: A Novel Biomanufacturing System for the Production of Monoclonal Antibodies and
                       Proteins in Cell Culture
                       Darryl Sampey – BioFactura, Inc.
        Noon–6:00 pm: Free Afternoon with Recommended Activities
          6:00–9:00 pm: Conference Banquet — Capitol City Brewing Company

Wednesday, December 6
         7:30–8:30 am: Continental Breakfast — Meeting Room Foyer
         8:30–9:15 am: Characterization of Novel Cell Substrates for Manufacture of Viral Vaccines
                       Arifa Khan, Ph.D. – FDA CBER
        9:15-10:00 am: Workshop I

        10:00–10:30 am: Break — Meeting Room Foyer
           10:30–Noon: Panel Discussion – Scientific Challenges for Production Cell Banks
                        Arifa Khan, Ph.D. – FDA CBER (Chair)
         Noon–1:30 pm: Lunch — Meeting Room Foyer
          1:00–1:30 pm: Poster Session
          1:30–2:15 pm: Characterization of Novel Cell Substrates for Manufacture of Viral Vaccines
                        Arifa Khan, Ph.D. – FDA CBER



                 Due to circumstances beyond the control of the conference organizers, the program is subject to change.
                            The Williamsburg BioProcessing Foundation
                            The Most Trusted Source of BioProcess Technology®



                            Cell Engineering and Banking
                                            Optimizing Productivity, Stability and Safety

December 4-6, 2006                                                                                                        Washington, D.C.
                                                         Registration Form
       Guest/Spouse Fee:
       For an additional $95, a guest or spouse can                                              Corporate        Non-Profit        Academic/Gov't
       join you for the evening receptions and banquet.              Full Conference                 $1,695          $895             $350
                                                                     Single Day                      $650            $350             $150
       Simply include payment and the person’s name:
                $95 Guest/Spouse
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Please make your check payable to “WilBio” in U.S. dollars, and send it to the address shown at                                Send me info on:
the bottom of the page. If paying with a charge card, please indicate card type:                                                  Sponsorship
        Discover        Visa         MasterCard           American Express                                                        Workshops
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Hotel Accommodations
The Washington Court Hotel has offered a special rate of $219 per night plus applicable sales tax. All reservations must be
made directly with the hotel.
          Washington Court Hotel
          525 New Jersey Avenue
          Washington, D.C. 20001-1527
To receive the conference rate of $219, you must reserve your room no later than November 17, 2006. Please specify that you will
be attending the Cell Engineering and Banking Conference.

Cancellation Policy
We will reimburse your registration fee less a $100 cancellation charge if we receive a written cancellation request no later than
November 4, 2006. No refunds are available after this date.

Due to circumstances beyond the control of the conference organizers, the program and speaker list are subject to change.


 P.O. Box 1229, Virginia Beach, Virginia 23451   •   Phone: 757.423.8823   •     Fax: 757.423.2065   •   www.wilbio.com   •   E-mail: info@wilbio.com