SAFC Pharma®'s St. Louis HPAPI Conjugates Facility Receives SafeBridge® Certification
|St. Louis, MO – June 1, 2009 – SAFC Pharma® (www.safcpharma.com), a business segment of SAFC®, a member of the Sigma-Aldrich® Group (NASDAQ: SIAL), today announced the certification of its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite, by SafeBridge® 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 ft2 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 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®, SAFC Supply Solutions®, SAFC Biosciences®, and SAFC Hitech® – 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®: 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®: : 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 www.sigma-aldrich.com.
SAFC®, SAFC Pharma®, SAFC Hitech® and Sigma-Aldrich® are registered trademarks of Sigma Biotechnology L.P. and Sigma-Aldrich Co.
SafeBridge® is a registered trademark of SafeBridge Consultants Inc.
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