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Portfolio for the pharmaceutical industry

Portfolio for the pharmaceutical industry · 4 | Drug discovery> Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging Metabolite Profiling

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Page 1: Portfolio for the pharmaceutical industry · 4 | Drug discovery> Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging Metabolite Profiling

Portfolio for the pharmaceutical industry

Page 2: Portfolio for the pharmaceutical industry · 4 | Drug discovery> Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging Metabolite Profiling

Expertise across the entire value chain

Metabolite

Profi ling

Catalysts

Solvents

Building

Blocks

Custom

Synthesis

Reagents

Generic

APIs

Excipients

Plastics for

Healthcare &

Diagnostics

Anti-Counter-

feiting

Protective

Groups

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

2000

BASF builds its first biocatalysis plantin Ludwigshafen, producing ChiPros®

– high-quality chiral amines

Focused on your needs

BASF provides products and services for the pharmaceut -

ical industry that enhance your competitiveness. We

focus firmly on meeting your needs. As a result, BASF is

At BASF, we know that innovation, speed-to-market, and

cost-effectiveness are key to pharmaceutical companies.

With our comprehensive portfolio and unparalleled skills at

every stage of the pharmaceutical value chain, we pro-

vide the support you need to deliver on all three counts.

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

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

2003

Acquisition of Callery Chemical– the expert in boron and alkalimetal reagents

2003

Foundation of metanomics Health(BASF affiliate) – the specialist inmetabolite profiling

2005

Acquisition of Orgamol – acompany with half a century ofexperience and expertise incustom synthesis

2006

Acquisition of Engelhard – theexpert in catalysts; makingBASF the largest catalyst pro-ducer worldwide

not only a reliable and efficient supplier of standard prod-

ucts; we are also a trusted partner when it comes to

developing tailor-made solutions and processes.

What’s more, we foster effective collaboration and know-

ledge transfer between the teams responsible for our

various products and services. So when you partner with

us, you can count on truly end-to-end expertise.

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

Page 3: Portfolio for the pharmaceutical industry · 4 | Drug discovery> Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging Metabolite Profiling

Leading the way in innovation

Our success – and yours – is built on research and innov -

ation. At BASF, that means more than just new products;

it also encompasses enhanced processes. Around 8,300

BASF specialists worldwide leverage our extensive ex-

perience and expertise to conduct ongoing R&D across

virtually all chemical disciplines.

Interdisciplinary and international collaboration, including

cooperation with external partners, such as universities

and industry players, helps ensure we remain at the lead-

ing edge.

Verbund – the power of networking

BASF’s Verbund is one of our greatest assets when it

comes to getting the best out of our resources. Our Pro-

duction Verbund links our individual plants, enabling us to

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 know ledge to generate new ideas – and work hand

in hand with you to develop solutions that create value for

all stake holders.

Ensuring high quality standards

Consistently high quality is our top priority – and not just

because pharmaceutical production is subject to strin-

gent regulations. We also have our own rigorous internal

stand ards.

Our manufacturing facilities are certified to ISO 9001 and

fulfill current Good Manufacturing Practice (cGMP) stand -

ards, where required. They are regularly inspected by

national and international authorities, including the US Food

and Drug Administration (FDA).

New European chemicals legislation (REACH) places even

greater demands on companies with regard to product

stewardship and information on substance safety. To help

you achieve REACH compliance, BASF has pooled its skills

in EU chemicals legislation, and offers made-to-measure

service packages.

Drug Discovery > Preclinical Studies > Clinical Phases I-I I I > API Manufacturing > Drug Formulation > Packaging | 3

The following pages provide an overview of our portfolio. For further details, check out the enclosed CD.

These include:

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

� Acetylene chemistry

� Alkoxylation

� Amination

� Asymmetric borane reduction

� Asymmetric hydrogenation

� Asymmetric synthesis

� Azide chemistry

� Biotransformations

� Bromination

� Carbonylation

� C-C coupling

� Chinoline synthesis

� Chlorination

� Chloromethylation

� Cryogenic reactions

� Electrochemistry

� Enzyme technologies

� Grignard reactions

� HCN chemistry

� Heterogeneous catalysis

� High-pressure reactions

� Hydrazine chemistry

� Hydroformylation

� Hydrogenation

� Ionic liquid technologies

� N-, O-Heterocycles synthesis

� Olefin/Polyene chemistry

� Organometallic chemistry

� Organylzinc chemistry

� Oxamination

� Phosgene chemistry

� Phosphorous chemistry

� Photochemistry

� Polymerization (all types)

� Suzuki coupling

� Wittig reaction

Page 4: Portfolio for the pharmaceutical industry · 4 | Drug discovery> Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging Metabolite Profiling

4 | Drug discovery > Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging

Metabolite Profilingmetanomics Health, a BASF affiliate, applies metabolite

profiling to identify and apply biomarkers for drug discovery

and development, diagnostics, and nutritional research.

This supports and accelerates various phases of the drug

development chain by reducing risk and increasing efficacy

and response rates.

Applications

� Drug development and toxicology

• Early identification and classification of

toxicity mode of actions

• Increased mechanistic understanding

• Identification of biomarkers for efficacy

and pharmacology

• Support for compound ranking and decision-making

• Stratification of patients

• Differentiation of responders and non-responders

� Disease diagnostics and prognostics

MetaMapTM Database

� Toxicology metabolome database for prediction

and classification

www.metanomics-health.de

At BASF, we continuously apply our expertise in surface

and material science to develop new catalytic technolo-

gies. Our state-of-the-art precious-metal deposition tech-

nologies allow us to fine-tune formulations to the specific

needs of our customers’ chemistry and equipment. Our

comprehensive precious-metal services enable you to

focus on metal application, and not on non-value-added

services (e.g. transit or recovery).

What we offer:

� A comprehensive portfolio of homogeneous and hetero-

geneous catalysts for fine-chemical applications

� A wide range of selective (precious-metal) adsorbents

� Deep understanding of customers’ processes and needs

� Global manufacturing and R&D resources

� One of the broadest offerings of customized base-metal

and precious-metal catalysts available

� Full-loop precious-metal services and

� The best technical service in the business

www.catalysts.basf.com/pharma

Catalysts

Page 5: Portfolio for the pharmaceutical industry · 4 | Drug discovery> Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging Metabolite Profiling

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

BASF produces high-quality solvents that meet the specific

needs of the pharmaceutical industry. We also offer com-

prehensive packages of auxiliary services and newly de-

veloped solutions for selected products. An outstanding

example is our THF Pharma super dry, which has an ex-

tremely low water content (50 ppm), and is the solvent of

choice for many water-sensitive reactions.

Selected products:

� N,N’-Dimethylpropylene urea (DMPU)

� N-Methylpyrrolidone (NMP)

� Tetrahydrofuran pharma (THF)

� Dimethylformamide (DMF)

� N,N-Dimethylacetamide (DMAC)

� Dioxane

www.pharma-intermediates.basf.com

Solvents

Protective GroupsIn numerous complex synthesis routes for APIs, some

functional groups have to be shielded against conversion

in a specific reaction step. For this purpose, BASF offers a

range of compounds that provide the necessary protection

in your transformations. Various types of functions, ranging

from alcohols to amines, can be protected.

Selected products:

� Methylchloroformate

� Benzylchloroformate

� Dihydropyran (DHP)

� Pivaloyl chloride

� Benzophenone imine

www.pharma-intermediates.basf.com

Reagents

Dr. Daniela Proske is a firm believer in the power of

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.

BASF’s portfolio includes organic reagents and inorganic

specialty reagents (e.g. MeCBS), various boranes, specialty

bases and organozinc building blocks, as well as chiral

amines that facilitate reactions with high selectivity. To

support your development work from lab to launch, all

reagents are available in quantities from kilograms to tons.

Organic Reagents

� Chiral amines

� Diazabicycloundecene (DBU)

� Triphenylphosphine (TPP)

� Triethylamine

� Piperidine

� Hünig base

� Formic acid

www.pharma-intermediates.basf.com

Inorganic Specialty Reagents

� Alkali metal alcoholates

� Alkali amides

� Hydroxylamine and derivatives

� Boron trifluoride (complexes)

� Organozinc reagents

� Borane complexes

� Amine boranes

� Chiral boranes

� Alkylboranes

� Suzuki coupling reagents

www.pharma-inorganics.basf.com

Page 6: Portfolio for the pharmaceutical industry · 4 | Drug discovery> Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging Metabolite Profiling

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

Custom SynthesisBASF produces customized active ingredients and ad-

van ced intermediates exclusively on behalf of pharma -

ceu t i cal companies – and in complete confidence. Our

experts offer support throughout the drug lifecycle: from

kilo laboratory to commercial production, from the early

clinical phase to market launch, and even when the drug

becomes generic. When you join forces with our team, you

benefit from an extensive range of skills and technologies.

Over 600 m3 cGMP-compliant reactor capacity in

� Evionnaz (Switzerland)

� Saint-Vulbas (France)

� Ludwigshafen and Minden (Germany)

www.pharma-ingredients.basf.com/custom-synthesis

Building BlocksBASF’s innovative technology platform and our extensive

expertise in biocatalysis enable us to manufacture a wide

range of building blocks. Our offerings include a large

number of chiral intermediates and non-chiral specialties,

e.g. heterocycles and acid chlorides. Under the ChiPros®

trademark, BASF provides the world’s most extensive

portfolio of chiral amines, alcohols, acids and epoxides –

a portfolio that is steadily growing. Through the develop-

ment of tailor-made building blocks, we can assist your

drug discovery process from the early stages to launch.

ChiPros®: e.g. R-2-Chloromandelic acid, S-Phenyl-

propyl amine, R-Styrene oxide

Heterocycles: e.g. piperazine, imidazoles, pyrrols,

pyrazoles

Acid chlorides

Specialty amines: e.g. 2,6 Xylidine, tert. butylamine,

3-Amino-1-propanol, pyrrolidine, methoxypropylamine,

dimethylaminopropanol

www.pharma-intermediates.basf.com

Dr. Raphaël Gabioud and his colleagues know the value of teamwork.

Dr. Raphaël Gabioud, an expert in custom synthesis at BASF, was tasked

with enhancing the production process for an advanced intermediate used

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

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.

Page 7: Portfolio for the pharmaceutical industry · 4 | Drug discovery> Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging Metabolite Profiling

Drug Discovery > Preclinical Studies > Clinical Phases I-I I I > API Manufacturing > Drug Formulation > Packaging | 7

BASF provides generic active ingredients for many thera-

peutic fields of application, and is the market leader in

caffeine, ibuprofen, pseudoephedrine and theophylline.

More over, BASF offers a broad portfolio of smaller volume

specialty APIs.

Selected applications

� Analgesics

� Anesthetics

� Nervous system

� Dermatica

� Respiratory system

� Stimulant

� Urinary system

www.pharma-ingredients.basf.com/active-ingredients

Generic APIs

When it comes to a broad portfolio of excipients with ex-

ceptional potential, it’s hard to surpass BASF. The product

spectrum – particularly the Kollidon® and Kollicoat® ranges

– fulfills all the functional and regulatory requirements for

excipients used in the production of tablets, sprays or drops.

Applications

� Binders

� Coatings

� Controlled release

� Direct-compressible excipients

� Disintegrants

� Excipients for orally disintegrating tablets

� Solubilizers, solvents and cosolvents

www.pharma-ingredients.basf.com/excipients

Excipients

Plastics for Healthcare & Diagnostics*

Anti-CounterfeitingProtect your brands and consumers’ health – by lever -

a ging BASF’s extensive experience in safeguarding prod-

ucts, banknotes and documents.

We offer

� Customer-specific security levels

� Overt and covert solutions

� Guaranteed confidentiality and supply-chain security

Packaging applications include

� Board

� Labels

� Leaflets

� Printing inks

� Coatings

BASF provides four different high-performance plastics for

the healthcare and diagnostics market (HD). What’s more,

we offer services and assurances that are unparalleled in

the industry.

Products

� Terlux® HD (MABS)

� Terluran® HD (ABS)

� Luran® HD (SAN)

� Ultraform® PRO (POM)

Applications

� Connectors

� Inhaler housings

� Urine containers

� Valves, springs and sliding elements

Our service package for the healthcare and diagnostics

industry includes an undertaking not to change the resin

formulation – as defined in the Drug Master File (DMF) –

or, where such changes are necessary, to announce them

at least three years in advance. BASF also tests the com-

patibility of its plastics with specific chemicals, and helps

customers gain relevant approvals worldwide.

www.plasticsportal.eu/hd-plastics

* BASF has not designed or tested its plastics with respect to all of the special requirements re-la t ed to their use in medical devices and pharmaceutical applications. Therefore, BASF makesno warranties concerning the suitability of any BASF plastics for use in any medical deviceand pharmaceutical applications. Subject to an evaluation and a release in each individual caseand, if necessary, acceptance of a disclaimer by the customer, BASF is in general prepared tosupply plastics for medical applications. However, BASF does not supply its plastics for themanufacture of implants in any risk class. In all cases the BASF customers have to establishfrom their own experience and from tests on BASF plastics, that these plastics are suitable forthe manufacture of products for medical applications or pharmaceutical applications and thecustomers have to ensure that the medical device or pharmaceutical application manufacturedusing BASF plastics is safe, lawful and technically suitable for the intended use.

Page 8: Portfolio for the pharmaceutical industry · 4 | Drug discovery> Preclinical Studies > Clinical Phases I-III > API Manufacturing > Drug Formulation > Packaging Metabolite Profiling

Last

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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 faithand 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 particularpurpose 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.NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS, DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE SHALL THE DESCRIPTIONS,INFORMATION, DATA OR DESIGNS PROVIDED BE CONSIDERED A PART OF OUR TERMS AND CONDITIONS OF SALE. (August 2008).

Beachwood

Washington, D.C.

São Paulo

Antwerp Ludwigshafen

Rome

Mumbai

Shanghai

Nanjing

RoxburyEvans City

Seneca

Geismar

Bishop

Camaçari

Caojing

UlsanYeosu

St. Vulbas Evionnaz

MindenDe MeernBerlin

Iselin

● metanomics Health

● cGMP Sites (e.g. APIs, Excipients, ChiPros®, Custom Synthesis)

● Chemicals (e.g. Building Blocks, Reagents, Catalysts, Solvents)

■ Technical Service Centers/R&D sites

Metabolite Profiling

Dr. Kristina Busch

+49 30 3480-7121

[email protected]

Catalysts

Tiny Koelewijn

+31 30 666-9309

[email protected]

Inorganic Specialty Reagents

Dr. Felix Görth

+1 724 538-1317

[email protected]

Organic Reagents, Solvents, Building

Blocks, Protective Groups

Dr. Martin Merger

+49 621 60-44614

[email protected]

Custom Synthesis

Dr. Folker Ruchatz

+41 27 766-1220

[email protected]

Generic APIs

Brigitte Sebastian

+41 27 766-1612

[email protected]

Excipients

Dr. Hubertus Folttmann

+49 621 60-28560

[email protected]

Plastics for Healthcare & Diagnostics

Marcela Villegas

+49 621 60-45264

[email protected]

Anti-Counterfeiting

Szymon Siuda

+49 621 60-43062

[email protected]

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

BASF helps its customers in virtually all industries to be more successful.

With its high-value products and intelligent solutions, BASF plays an im-

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:

www.basf.com

BASF is close to you – all around the globe