SAFC Pipeline Partners

Complex technologies

Targeted Drug Delivery Through

Bio-Conjugation
As an industry leader in the conjugation of biological molecules with high potency APIs (HPAPIs), SAFC
Pharma™ is among a handful of companies that can carry out the complexities of conjugation of biological
molecules with HPAPIs.

While conjugation of biological molecules to non potent APIs is an established technology in which SAFC has
more than 30 years of experience, conjugation with highly-potent molecules is much more complex, primarily
because of the containment requirements needed when working with cytotoxic molecules.

SAFC Pharma’s financial strength and its focus on complex technologies has allowed specific and significant
investments in these areas providing clients with potent and non-potent APIs, linkers, and cGMP bio-
conjugation. Customers are quickly adapting these complex technologies and employing them to develop
new oncology products that are more targeted and exponentially more powerful.

Antibody Drug Conjugates (ADCs)

Antibody-drug conjugation technology uses

monoclonal antibodies or other biologics to
deliver conjugated highly-potent APIs
(HPAPIs) to targeted cells. In conjugated
form, the HPAPI exhibits more selective
cytotoxicity, thereby, sparing non-target cells
from many of the toxic effects.

For antibody drug conjugates, SAFC Pharma

provides development and manufacturing
services for the HPAPI (SAFC Pharma-
Madison’s Safebridge® certified
manufacturing), linker and conjugation.
Analytical tests for both APIs and biologics
have been developed and are available
to customers.

SAFC Pharma’s pilot-scale bio-conjugation

facility (St. Louis, MO) was purpose-built for
the handling of HPAPIs, antibodies, linkers,
and for performing complex conjugation
processes in cGMP suites featuring isolators
and specialized handling equipment. The
clinical manufacturing facility has been
validated (2008) and has capacity in place for
commercial-scale manufacturing of ADCs.

www.safcpharma.com
SAFC Pipeline Partners
®

Complex technologies

Targeted Drug Delivery Through

Bio-Conjugation

Manufacturing Capabilites Linkers

HPAPIs are often cytotoxic or neurotoxic
and must be handled with the highest level
of containment. SAFC’s facilities incorporate
appropriate room pressurization, airlocks,
ventilation and isolators to ensure proper
handling of these highly-potent materials.
SAFC’s high-potent manufacturing suites
can handle:
SAFC Pharma has partnered with a number of
leading companies in developing conjugation
products. The company has developed its own
proprietary linkers, and has also synthesized
many client-specific linkers that have proven to
be consistent and scaleable.
Drug + Protein

• HPAPIs manufactured at SAFC Pharma’s

Madison site
• Traditional (non-potent) APIs from global
SAFC or client facilities
• Linkers with unique conjugation
properties Drug High Potency Conjugate
(Drug-protein Conjugate)
• Bio-conjugation processes performed in
Protein
cGMP suites featuring isolators and
specialized handling equipment for
HPAPIs, in addition to pressurization and
facility design consistent with biologics
manufacturing
• Conjugation for linking of non-potent Drug

APIs to other biologic carriers, such as

Cancer Cell Protein
poly-amino acids or poly-nucleotides The protein part of the
conjugate recognizes the
cancer cells and binds to
them. The drug part kills the
cancer cells.

High-potent conjugation process scheme

COMMERCIALIZATION
PRE-CLINICAL
PHASE 2 PHASE 3
PHASE 1

SAFC Provides conjugation services to support pre-clinical and clinical trial scale
materials, with space for expansion as projects move towards commercialization

® ®
Sigma-Aldrich and SAFC 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
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