Safc Pharma - High-potent Apis And Cytotoxics

SAFC Pipeline Partners ®

Complex Technology

Development and Manufacturing

High-Potent APIs and Cytotoxics SAFC Pharma’s™ leading position in the fast-growing High-Potency Active Pharmaceutical Ingredients (HPAPI) market includes conjugation of HPAPIs to antibodies for exciting new anti-cancer drugs. HPAPIs (often cytotoxics, prostaglandins or hormones) are proven to be effective at much smaller dosage levels than traditional APIs, but their potent characteristics present specific handling challenges. With more than 15 years experience in HPAPI manufacturing, SAFC’s purpose-built facilities with specialized containment engineering ensure the reliable, safe and quick handling of HPAPIs throughout the development process.

High-Potent Small Molecule APIs SAFC Pharma’s Madison, Wisconsin facility has a complete range of kilo labs, pilot plants, and commercial capabilities for the manufacture of HPAPIs. This facility incorporates appropriate room pressurization, airlocks, ventilation and isolators to properly handle these highlypotent materials. The site has been certified by Safebridge® since 2003 to work with HPAPI compounds. High-Potent Bio-Conjugation SAFC is one of only a handful of manufacturing companies that can combine the critical expertise both in HPAPI and biologics to commercialize high-potent bio-conjugates. SAFC has dedicated high-containment cGMP suites in St. Louis, Missouri, specifically designed for conjugation of HPAPIs to antibodies or other therapeutic proteins, to combine high potency materials for use in targeted therapies. High-Potent Fermentation SAFC has a new containment facility based in Israel that focuses on production of secondary metabolites, cytotoxins, and highly-potent largemolecule proteins. The Israel fermentation facility includes blast-proof cleanroom suites and containment pressurization.

www.safcpharma.com

SAFC Pipeline Partners ®

Complex Technology

Development and Manufacturing High-Potent APIs and Cytotoxics Analytical Services

Clinical to Commercial

SAFC Pharma™ provides complete

The company provides comprehensive

analytical support, including development

development and manufacturing services

of specifications, development and risk-

for HPAPIs and cytotoxics in FDA-inspected

assessment, implementation of

facilities from clinical to commercial-scale

process controls.

quantities.

• Analytical capabilities includes:

Quality Management

– LCMS

– UV

– HPLC

– IR

– GC

– NMR

• Highly-experienced personnel

– GCMS

– FT-IR

• Operations to industry standards

– TGA

– KF

– Proven and experienced quality assurance

– X-ray diffraction

– ELISA



– Bioburden

– Endotoxin

– Clinical trials APIs manufactured to

• Dedicated Quality Assurance (QA) units

oversight for HPAPIs

– Electrophoresis



– Amino Acid Analysis (AAA)

ICH Q7A guidelines

• Rigorous compliance program in place

• Phase-specific analytical development and method validation • Characterization, certification, and control of incoming raw materials

Project Management SAFC’s project managers lead multi-functional teams in support of custom cGMP projects. Our Project Managers serve as a single point of

• Quality Control (QC) testing of in-process

contact for customers, and help facilitate the timely communication of important technical

materials

information and production timelines.

• Release testing available • Stability studies of drug substance and drug product • Pharmorphix® solid state chemistry services for every API developed and manufactured at SAFC

COMMERCIALIZATION

PRE-CLINICAL

PHASE 2

PHASE 1

PHASE 3

SAFC Pharma can support customers with its complex high-potency manufacturing technologies from pre-clinical to commercialization.

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Sigma-Aldrich, SAFC and Pharmorphix are registered trademarks and SAFC Pharma™ is a trademark of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co. ® Safebridge is a registered trademark of Safebridge Consultants Inc. © 2008 SAFC All rights reserved.

04516-506486 KPU 0088

www.safcpharma.com