SAFC Pharma's St. Louis HPAPI Conjugates Facility Receives SafeBridge Certification

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Mon Jun 1, 2009 7:00am EDT

SAFC Pharma's St. Louis HPAPI Conjugates Facility Receives SafeBridge
Certification

ST. LOUIS, June 1 /PRNewswire-FirstCall/ -- SAFC Pharma(R)
(www.safcpharma.com), a business segment of SAFC(R), a member of the
Sigma-Aldrich(R) Group (Nasdaq: SIAL), today announced the certification of
its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite,
by SafeBridge(R) Consultants, Inc. for the safe handling of potent drug
substances. The suite, located on the company's St. Louis, Missouri campus was
designed to support the entire drug development pipeline, from early-stage
clinical supplies to kilogram quantities, and expandable to commercial-scale. 

The 600 square ft HPAPI suite, commissioned in September 2008, enables the
conjugation of Highly Potent Active Pharmaceutical Ingredients
(www.safcpharma.com/hpapi) to a variety of targeted delivery molecules known
as antibody drug conjugates (ADCs). 

"Gaining SafeBridge certification status for our HPAPI conjugation suite
provides our customers with complete confidence in our ability to handle their
potent compound projects safely and efficiently," commented David Feldker,
SAFC Pharma Vice President. "This adds to our already significant experience
in the production of HPAPIs, an area in which we continue to see rapid growth
as targeted oncology evolves. The suite builds upon 15 years of HPAPI
manufacturing experience at SAFC's Madison, Wisconsin site, which is also
SafeBridge certified, and upon more than 30 years of experience in conjugation
technology at the St. Louis facility." 

The SafeBridge program assessment, recognized as the most widely accepted
industry benchmark for handling highly potent pharmaceuticals, focuses on four
primary areas: (1) management, (2) hazard identification and evaluation, (3)
hazard controls, and (4) communication, education and training.

The new SafeBridge certification of the St. Louis HPAPI suite adds to SAFC
investments totaling $75 million during the past 18 months to expand its HPAPI
capacity. Those include a $4.5 million project to add a cGMP pilot plant and
kilo-lab capacity at the Madison facility, completed in early 2008; a $29
million investment to expand bacterial and fungal fermentation derived HPAPI
capacity at Jerusalem, Israel, due for completion in early 2010; and a $30
million investment to build a new commercial-scale HPAPI facility at Madison,
due to be completed by year-end 2009. 

About SAFC: SAFC(R) is the custom manufacturing and services group within
Sigma-Aldrich that focuses on high-purity inorganics for high technology
applications, cell culture products and services for biopharmaceutical
manufacturing, biochemical production and the manufacturing of complex,
multi-step organic synthesis of APIs and key intermediates. SAFC has
manufacturing facilities around the world dedicated to providing manufacturing
services for companies requiring a reliable partner to produce their custom
manufactured materials. SAFC has four business segments - SAFC Pharma(R), SAFC
Supply Solutions(R), SAFC Biosciences(R), and SAFC Hitech(R)- and had annual
sales of over $600 million in 2008. SAFC is considered a top 10 fine chemical
company. For more information about SAFC, visit www.safcglobal.com.

About SAFC Pharma(R): SAFC Pharma is a complete pipeline partner for the
development and cGMP custom manufacturing of complex small-molecule APIs and
biologic drug products. It combines world-class project management and
chemistry support for all stages of the drug discovery and development process
from research and discovery, through pre-clinical and clinical development to
commercialization, with a focus on reducing the drug development time-line.
SAFC has the widest range of raw materials, highly qualified and experienced
staff, state-of-the-art facilities and an integrated portfolio of services,
including full analytical and regulatory support and is a leader in emerging
technologies, including high-potency APIs, solid-state chemistry, viral
products and chemical-biologic API conjugates. For more information visit
www.safcpharma.com.

About Sigma-Aldrich(R): Sigma-Aldrich is a leading Life Science and High
Technology company. Its biochemical and organic chemical products and kits are
used in scientific research, including genomic and proteomic research,
biotechnology, pharmaceutical development and as key components in
pharmaceutical, diagnostic and other high technology manufacturing. The
Company has customers in life science companies, university and government
institutions, hospitals, and in industry. Over one million scientists and
technologists use its products. Sigma-Aldrich operates in 38 countries and has
7,800 employees providing excellent service worldwide. Sigma-Aldrich is
committed to Accelerating Customer Success through Innovation and Leadership
in Life Science, High Technology and Service. For more information about
Sigma-Aldrich, please visit its award-winning Web site at
http://www.sigma-aldrich.com.

SAFC(R), SAFC Pharma(R) , SAFC Hitech(R) and Sigma-Aldrich(R) are registered
trademarks of Sigma Biotechnology L.P. and Sigma-Aldrich Co.

SafeBridge(R) is a registered trademark of SafeBridge Consultants Inc.



SOURCE  Sigma-Aldrich Corporation

David Feldker, Vice President of SAFC Pharma, +1-314-289-8467; or Media, Mark
Button of Impress Public Relations, +1-408-852-1789, mark@impress-pr.com, for
Sigma-Aldrich Corporation
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