Safc Pharma - Targeted Drug Delivery Through Bio-conjugation

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 bioconjugation. 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 PharmaMadison’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

SAFC Pharma has partnered with a number of

and must be handled with the highest level

leading companies in developing conjugation

of containment. SAFC’s facilities incorporate

products. The company has developed its own

appropriate room pressurization, airlocks,

proprietary linkers, and has also synthesized

ventilation and isolators to ensure proper

many client-specific linkers that have proven to

handling of these highly-potent materials.

be consistent and scaleable.

SAFC’s high-potent manufacturing suites can handle:

+

Drug

• HPAPIs manufactured at SAFC Pharma’s

Protein

Madison site • Traditional (non-potent) APIs from global SAFC or client facilities • Linkers with unique conjugation properties

High Potency Conjugate (Drug-protein Conjugate)

Drug

• 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 Protein

Cancer Cell

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 1

PHASE 2

PHASE 3

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 KPX 0088

www.safcpharma.com