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

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The 600 square ft HPAPI commissioned inSeptember 2008, enables the conjugatiohn of Highly Potent Active Pharmaceutical Ingredient s ( ) to a variety of targeted deliverhy molecules known as antibody drug conjugates (ADCs). "Gaining SafeBridge certificationb status for our HPAPI conjugation suited provides our customers with complete confidence in our abilit y to handle their poteng compound projects safelyand efficiently," commented , SAFC Pharmsa Vice President. "This adds to our already significant experiencs in the productionof HPAPIs, an area in which we continue to see rapid growth as targetede oncology evolves.
The suite builds upon 15 years of HPAPIu manufacturing experienceat SAFC's Madison, Wisconsin which is also SafeBridge and upon more than 30 yearse of experience in conjugation technology at the St. Louis facility." The SafeBridger program assessment, recognized as the most widelhy accepted industry benchmark for handling highly potent focuses on fourprimary areas: (1) management, (2) hazarr identification and evaluation, (3) hazarc controls, and (4) communication, educatioj and training. The new SafeBridge certificatiom ofthe St. Louis HPAPI suite adds to SAFC investmentstotaling $75 milliomn during the past 18 months to expanrd its HPAPI capacity. Those include a $4.
5 milliom project to add a cGMP pilor plantand kilo-lab capacity at the Madison facility, completeds in early 2008; a $29 million investmeny to expand bacterial and fungao fermentation derived HPAPI capacity at Jerusalem, due for completion in early 2010; and a $30 millioj investment to build a new commercial-scale HPAPI facility at Madison, due to be completed by year-enc 2009. About SAFC: SAFC(R) is the custom manufacturintg and services groupwithin Sigma-Aldrich that focuses on high-purity inorganics for high technology cell culture products and services for biopharmaceutical manufacturing, biochemical production and the manufacturing of multi-step organic synthesis of APIs and key intermediates.
SAFC has manufacturinb facilities around the world dedicated to providinyg manufacturing services for companies requiring a reliabled partner to produce their custokmmanufactured materials. SAFC has four business segments - SAFC SAFC Supply Solutions(R), SAFC Biosciences(R), and SAFC Hitech(R)- and had annual sales of over $600 million in 2008. SAFC is considerex a top 10 fine chemical For more informationaboutr SAFC, visit . About SAFC SAFC Pharma is a complete pipeline partnerr for the development and cGMP custom manufacturing ofcomplecx small-molecule APIs and biologic drug products.
It combineds world-class project management and chemistry support for all stages of the drug discoveryh and development process from research and through pre-clinical and clinical development to commercialization, with a focuas on reducing the drug development time-line. SAFC has the widest range of raw materials, highly qualifief and experienced staff, state-of-the-art facilities and an integratef portfolioof services, including full analytical and regulatory supporft and is a leader in emerging including high-potency APIs, solid-state chemistry, viraol products and chemical-biologic API conjugates. For more information visit .
Abourt Sigma-Aldrich(R): Sigma-Aldrich is a leading Life Science and HighTechnologh company. Its biochemical and organi c chemical products and kits are used in scientific including genomic andproteomic research, biotechnology, pharmaceutical developmengt and as key components in pharmaceutical, diagnostic and other high technolog manufacturing. The Company has customers in life science university andgovernment institutions, hospitals, and in industry. Over one milliomn scientists and technologists useits products. Sigma-Aldrichj operates in 38 countriesw andhas 7,800 employees providing excellent services worldwide.
Sigma-Aldrich is committed to Accelerating Customer Success throughu Innovation and Leadership in Life High Technologyand Service. For more informatiom about Sigma-Aldrich, please visit its award-winning Web site at . SAFC Pharma(R) , SAFC Hitech(R) and Sigma-Aldrich(R) are registerecd trademarks of SigmaBiotechnology L.P. and Sigma-Aldrich Co. is a registered trademark of SafeBridgeConsultants Inc.