Portfolio for the pharmaceutical industry

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Portfolio for the pharmaceutical industry Powered By Docstoc
					Portfolio for the
pharmaceutical industry
2 | Drug Discovery > Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging

Expertise across the entire value chain
At BASF, we know that innovation, speed-to-market, and                                     What’s more, we foster effective collaboration and know-
cost-effectiveness are key to pharmaceutical companies.                                    ledge transfer between the teams responsible for our
With our comprehensive portfolio and unparalleled skills at                                various products and services. So when you partner with
every stage of the pharmaceutical value chain, we pro-                                     us, you can count on truly end-to-end expertise.
vide the support you need to deliver on all three counts.

Drug Discovery > Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging

                                        Solvents              Reagents

                                                                          Custom                                                                                    Anti-Counter-
                           Catalysts                                                                                  Excipients
                                                                         Synthesis                                                                                     feiting

                                                                                                                                             Plastics for
   Metabolite                                                                                    Generic
                                                                                                                                             Healthcare &
    Profiling                                                                                      APIs
                                       Protective             Building
                                        Groups                 Blocks

Our offerings focus on specific phases of the pharmaceutical value chain – but are usually not confined to one phase.

Focused on your needs
BASF provides products and services for the pharmaceut-                                    not only a reliable and efficient supplier of standard prod-
ical industry that enhance your competitiveness. We                                        ucts; we are also a trusted partner when it comes to
focus firmly on meeting your needs. As a result, BASF is                                   developing tailor-made solutions and processes.

We continuously extend and enhance our range of products and services.

  2000                                                        2003                                                                                2006
  BASF builds its first biocatalysis plant                    Acquisition of Callery Chemical                                                     Acquisition of Engelhard – the
  in Ludwigshafen, producing ChiPros®                         – the expert in boron and alkali                                                    expert in catalysts; making
  – high-quality chiral amines                                metal reagents                                                                      BASF the largest catalyst pro-
                                                                                                                                                  ducer worldwide

                       2003                                                                                 2005
                       Foundation of metanomics Health                                                      Acquisition of Orgamol – a
                       (BASF affiliate) – the specialist in                                                 company with half a century of
                       metabolite profiling                                                                 experience and expertise in
                                                                                                            custom synthesis
                                          Drug Discovery > Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging | 3

Leading the way in innovation                                           Ensuring high quality standards
Our success – and yours – is built on research and innov-               Consistently high quality is our top priority – and not just
ation. At BASF, that means more than just new products;                 because pharmaceutical production is subject to strin-
it also encompasses enhanced processes. Around 8,300                    gent regulations. We also have our own rigorous internal
BASF specialists worldwide leverage our extensive ex-                   standards.
perience and expertise to conduct ongoing R&D across
                                                                        Our manufacturing facilities are certified to ISO 9001 and
virtually all chemical disciplines.
                                                                        fulfill current Good Manufacturing Practice (cGMP) stand-
Interdisciplinary and international collaboration, including            ards, where required. They are regularly inspected by
cooperation with external partners, such as universities                national and international authorities, including the US Food
and industry players, helps ensure we remain at the lead-               and Drug Administration (FDA).
ing edge.
                                                                        New European chemicals legislation (REACH) places even
                                                                        greater demands on companies with regard to product
Verbund – the power of networking                                       stewardship and information on substance safety. To help
BASF’s Verbund is one of our greatest assets when it                    you achieve REACH compliance, BASF has pooled its skills
comes to getting the best out of our resources. Our Pro-                in EU chemicals legislation, and offers made-to-measure
duction Verbund links our individual plants, enabling us to             service packages.
create efficient and reliable value chains – ranging from
basic chemicals through to end-user products. We also
apply the Verbund principle to our research and know-
ledge management, and to teamwork among BASF em-
ployees. Pharma experts from all BASF divisions share
their knowledge to generate new ideas – and work hand
in hand with you to develop solutions that create value for
all stakeholders.

   At BASF, we leverage a wide range of technologies and reactions.

   These include:
     Acetylene chemistry              Carbonylation                             HCN chemistry                                Organometallic chemistry
     Alkoxylation                     C-C coupling                              Heterogeneous catalysis                      Organylzinc chemistry
     Amination                        Chinoline synthesis                       High-pressure reactions                      Oxamination
     Asymmetric borane reduction      Chlorination                              Hydrazine chemistry                          Phosgene chemistry
     Asymmetric hydrogenation         Chloromethylation                         Hydroformylation                             Phosphorous chemistry
     Asymmetric synthesis             Cryogenic reactions                       Hydrogenation                                Photochemistry
     Azide chemistry                  Electrochemistry                          Ionic liquid technologies                    Polymerization (all types)
     Biotransformations               Enzyme technologies                       N-, O-Heterocycles synthesis                 Suzuki coupling
     Bromination                      Grignard reactions                        Olefin/Polyene chemistry                     Wittig reaction

   The following pages provide an overview of our portfolio. For further details, check out the enclosed CD.
4 | Drug discovery > Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging

Metabolite Profiling                                                                 Catalysts
metanomics Health, a BASF affiliate, applies metabolite                              At BASF, we continuously apply our expertise in surface
profiling to identify and apply biomarkers for drug discovery                        and material science to develop new catalytic technolo-
and development, diagnostics, and nutritional research.                              gies. Our state-of-the-art precious-metal deposition tech-
This supports and accelerates various phases of the drug                             nologies allow us to fine-tune formulations to the specific
development chain by reducing risk and increasing efficacy                           needs of our customers’ chemistry and equipment. Our
and response rates.                                                                  comprehensive precious-metal services enable you to
                                                                                     focus on metal application, and not on non-value-added
                                                                                     services (e.g. transit or recovery).
  Drug development and toxicology
   • Early identification and classification of                                      What we offer:
     toxicity mode of actions                                                         A comprehensive portfolio of homogeneous and hetero-
   • Increased mechanistic understanding                                              geneous catalysts for fine-chemical applications
   • Identification of biomarkers for efficacy                                        A wide range of selective (precious-metal) adsorbents
     and pharmacology                                                                   Deep understanding of customers’ processes and needs
    • Support for compound ranking and decision-making                                  Global manufacturing and R&D resources
    • Stratification of patients                                                        One of the broadest offerings of customized base-metal
    • Differentiation of responders and non-responders                                  and precious-metal catalysts available
   Disease diagnostics and prognostics                                                  Full-loop precious-metal services and
                                                                                        The best technical service in the business
MetaMapTM Database
 Toxicology metabolome database for prediction                                       www.catalysts.basf.com/pharma
 and classification

                                                       Drug Discovery > Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging | 5

Reagents                                                                                Solvents
BASF’s portfolio includes organic reagents and inorganic                                BASF produces high-quality solvents that meet the specific
specialty reagents (e.g. MeCBS), various boranes, specialty                             needs of the pharmaceutical industry. We also offer com-
bases and organozinc building blocks, as well as chiral                                 prehensive packages of auxiliary services and newly de-
amines that facilitate reactions with high selectivity. To                              veloped solutions for selected products. An outstanding
support your development work from lab to launch, all                                   example is our THF Pharma super dry, which has an ex-
reagents are available in quantities from kilograms to tons.                            tremely low water content (50 ppm), and is the solvent of
                                                                                        choice for many water-sensitive reactions.
Organic Reagents
  Chiral amines                                                                         Selected products:
  Diazabicycloundecene (DBU)                                                              N,N’-Dimethylpropylene urea (DMPU)
  Triphenylphosphine (TPP)                                                                N-Methylpyrrolidone (NMP)
  Triethylamine                                                                           Tetrahydrofuran pharma (THF)
  Piperidine                                                                              Dimethylformamide (DMF)
   Hünig base                                                                               N,N-Dimethylacetamide (DMAC)
   Formic acid                                                                              Dioxane

www.pharma-intermediates.basf.com                                                       www.pharma-intermediates.basf.com

Inorganic Specialty Reagents
  Alkali metal alcoholates
  Alkali amides                                                                         Protective Groups
  Hydroxylamine and derivatives
  Boron trifluoride (complexes)                                                         In numerous complex synthesis routes for APIs, some
  Organozinc reagents                                                                   functional groups have to be shielded against conversion
   Borane complexes                                                                     in a specific reaction step. For this purpose, BASF offers a
   Amine boranes                                                                        range of compounds that provide the necessary protection
   Chiral boranes                                                                       in your transformations. Various types of functions, ranging
   Alkylboranes                                                                         from alcohols to amines, can be protected.
   Suzuki coupling reagents
                                                                                        Selected products:
www.pharma-inorganics.basf.com                                                            Methylchloroformate
                                                                                          Dihydropyran (DHP)
                                                                                          Pivaloyl chloride
Dr. Daniela Proske is a firm believer in the power of                                     Benzophenone imine
global cooperation.
When her customer - the US subsidiary of a European-based
pharmaceutical company - requested a catalyst to optimize the
production process, Dr. Daniela Proske, a BASF expert in inter-
mediates, knew exactly who to call: her Dutch colleague, Dr. Jim
Brandts, at the Catalysts division. He designed a new type of cata-
lyst, which was supplied from the catalyst plant in the US. And
when the customer transferred development and scale-up to
Europe, the Catalysts division followed suit, moving activities to
Rome. What’s more, when commercial production got underway
at the customer’s Asian plant, local BASF staff were on hand to
manage catalyst shipments.
6 | Drug Discovery > Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging

Building Blocks                                                                       Custom Synthesis
BASF’s innovative technology platform and our extensive                               BASF produces customized active ingredients and ad-
expertise in biocatalysis enable us to manufacture a wide                             vanced intermediates exclusively on behalf of pharma-
range of building blocks. Our offerings include a large                               ceutical companies – and in complete confidence. Our
number of chiral intermediates and non-chiral specialties,                            experts offer support throughout the drug lifecycle: from
e.g. heterocycles and acid chlorides. Under the ChiPros®                              kilo laboratory to commercial production, from the early
trademark, BASF provides the world’s most extensive                                   clinical phase to market launch, and even when the drug
portfolio of chiral amines, alcohols, acids and epoxides –                            becomes generic. When you join forces with our team, you
a portfolio that is steadily growing. Through the develop-                            benefit from an extensive range of skills and technologies.
ment of tailor-made building blocks, we can assist your
                                                                                      Over 600 m3 cGMP-compliant reactor capacity in
drug discovery process from the early stages to launch.
                                                                                       Evionnaz (Switzerland)
ChiPros®: e.g. R-2-Chloromandelic acid, S-Phenyl-                                      Saint-Vulbas (France)
propylamine, R-Styrene oxide                                                           Ludwigshafen and Minden (Germany)

Heterocycles: e.g. piperazine, imidazoles, pyrrols,                                   www.pharma-ingredients.basf.com/custom-synthesis

Acid chlorides
                                                                                           Dr. Raphaël Gabioud and his colleagues know the value of teamwork.
Specialty amines: e.g. 2,6 Xylidine, tert. butylamine,                                     Dr. Raphaël Gabioud, an expert in custom synthesis at BASF, was tasked
3-Amino-1-propanol, pyrrolidine, methoxypropylamine,                                       with enhancing the production process for an advanced intermediate used
dimethylaminopropanol                                                                      in a complex API. He soon realized the synthesis route could be improved by
                                                                                           greater selectivity. Moreover, he knew that the necessary chiral amine could
www.pharma-intermediates.basf.com                                                          be developed by our in-house specialists – Prof. Dr. Klaus Ditrich and his
                                                                                           team. By drawing on BASF’s unique global network of skills and resources,
                                                                                           he was able to offer the customer a tailor-made solution to his needs.
                                                                Drug Discovery > Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging | 7

                                                                                                     Plastics for Healthcare
 Generic APIs                                                                                        & Diagnostics*
 BASF provides generic active ingredients for many thera-                                            BASF provides four different high-performance plastics for
 peutic fields of application, and is the market leader in                                           the healthcare and diagnostics market (HD). What’s more,
 caffeine, ibuprofen, pseudoephedrine and theophylline.                                              we offer services and assurances that are unparalleled in
 Moreover, BASF offers a broad portfolio of smaller volume                                           the industry.
 specialty APIs.
 Selected applications                                                                                Terlux® HD (MABS)
  Analgesics                                                                                          Terluran® HD (ABS)
  Anesthetics                                                                                         Luran® HD (SAN)
  Nervous system                                                                                      Ultraform® PRO (POM)
  Respiratory system
                                                                                                      Inhaler housings
    Urinary system
                                                                                                      Urine containers
 www.pharma-ingredients.basf.com/active-ingredients                                                   Valves, springs and sliding elements

                                                                                                     Our service package for the healthcare and diagnostics
                                                                                                     industry includes an undertaking not to change the resin
 Excipients                                                                                          formulation – as defined in the Drug Master File (DMF) –
                                                                                                     or, where such changes are necessary, to announce them
 When it comes to a broad portfolio of excipients with ex-                                           at least three years in advance. BASF also tests the com-
 ceptional potential, it’s hard to surpass BASF. The product                                         patibility of its plastics with specific chemicals, and helps
 spectrum – particularly the Kollidon® and Kollicoat® ranges                                         customers gain relevant approvals worldwide.
 – fulfills all the functional and regulatory requirements for
 excipients used in the production of tablets, sprays or drops.

  Controlled release
                                                                                                     Protect your brands and consumers’ health – by lever-
  Direct-compressible excipients
                                                                                                     aging BASF’s extensive experience in safeguarding prod-
                                                                                                     ucts, banknotes and documents.
  Excipients for orally disintegrating tablets
  Solubilizers, solvents and cosolvents                                                              We offer
                                                                                                      Customer-specific security levels
                                                                                                      Overt and covert solutions
                                                                                                      Guaranteed confidentiality and supply-chain security

* BASF has not designed or tested its plastics with respect to all of the special requirements re-   Packaging applications include
  lated to their use in medical devices and pharmaceutical applications. Therefore, BASF makes
  no warranties concerning the suitability of any BASF plastics for use in any medical device         Board
  and pharmaceutical applications. Subject to an evaluation and a release in each individual case
  and, if necessary, acceptance of a disclaimer by the customer, BASF is in general prepared to       Labels
  supply plastics for medical applications. However, BASF does not supply its plastics for the
  manufacture of implants in any risk class. In all cases the BASF customers have to establish        Leaflets
  from their own experience and from tests on BASF plastics, that these plastics are suitable for
  the manufacture of products for medical applications or pharmaceutical applications and the         Printing inks
  customers have to ensure that the medical device or pharmaceutical application manufactured
  using BASF plastics is safe, lawful and technically suitable for the intended use.                  Coatings
BASF is close to you – all around the globe
● metanomics Health

● cGMP Sites (e.g. APIs,
  Excipients, ChiPros®,                                                                                                   De Meern Minden
                                                                                                                         Antwerp      Berlin
  Custom Synthesis)                                                  Beachwood
                                                                                                                         St. Vulbas  Evionnaz
● Chemicals (e.g. Building Blocks,                             Evans City
                                                                                Washington, D.C.                                   Rome                                                                         Ulsan
  Reagents, Catalysts, Solvents)                                          Geismar                                                                                                                 Nanjing
■ Technical Service Centers/R&D sites                                                                                                                                                           Shanghai


                                                                                      São Paulo

Metabolite Profiling                                                         Organic Reagents, Solvents, Building                                         Excipients
Dr. Kristina Busch                                                           Blocks, Protective Groups                                                    Dr. Hubertus Folttmann
+49 30 3480-7121                                                             Dr. Martin Merger                                                            +49 621 60-28560
kristina.busch@metanomics-health.de                                          +49 621 60-44614                                                             hubertus.folttmann@basf.com
Catalysts                                                                                                                                                 Plastics for Healthcare & Diagnostics
Tiny Koelewijn                                                               Custom Synthesis                                                             Marcela Villegas
+31 30 666-9309                                                              Dr. Folker Ruchatz                                                           +49 621 60-45264
tiny.koelewijn@basf.com                                                      +41 27 766-1220                                                              marcela.villegas@basf.com
Inorganic Specialty Reagents                                                                                                                              Anti-Counterfeiting
Dr. Felix Görth                                                              Generic APIs                                                                 Szymon Siuda
+1 724 538-1317                                                              Brigitte Sebastian                                                           +49 621 60-43062
felix.goerth@basf.com                                                        +41 27 766-1612                                                              szymon.siuda@basf.com

BASF is the world’s leading chemical company: The Chemical Company.
Its portfolio ranges from oil and gas to chemicals, plastics, performance
products, agricultural products and fine chemicals. As a reliable partner
                                                                                                                                                                                                                                     ® = Registered Trademark of BASF

BASF helps its customers in virtually all industries to be more successful.
With its high-value products and intelligent solutions, BASF plays an im-
                                                                                                                                                                                                                                     Last update: August 2008

portant role in finding answers to global challenges such as climate protec-

tion, energy efficiency, nutrition and mobility.

Further information on BASF is available on the Internet at:

This document, or any answers or information provided herein by BASF, does not constitute a legally binding obligation of BASF. While the descriptions, designs, data and information contained herein are presented in good faith
and believed to be accurate, it is provided for your guidance only. Because many factors may affect processing or application/use, we recommend that you make tests to determine the suitability of a product for your particular
purpose prior to use. It does not relieve our customers from the obligation to perform a full inspection of the products upon delivery or any other obligation.