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 highly-
potent 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 large-
molecule 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
• Dedicated Quality Assurance (QA) units
– 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 oversight for HPAPIs

– Bioburden – Endotoxin – Clinical trials APIs manufactured to

– Electrophoresis ICH Q7A guidelines

– Amino Acid Analysis (AAA) • Rigorous compliance program in place

• Phase-specific analytical development and
Project Management
method validation
SAFC’s project managers lead multi-functional
• Characterization, certification, and control
teams in support of custom cGMP projects.
of incoming raw materials
Our Project Managers serve as a single point of
• Quality Control (QC) testing of in-process contact for customers, and help facilitate the
materials timely communication of important technical
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 3
PHASE 1

SAFC Pharma can support customers with its complex high-potency

manufacturing technologies from pre-clinical to commercialization.

® ® ®
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
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