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

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The 600 square ft HPAPI suite, commissionec in September 2008, enablews the conjugation of Highly Potent Active Pharmaceutical Ingredients ( ) to a variety of targeted deliver molecules known as antibody drug conjugates (ADCs). "Gaining SafeBridged certification status for our HPAPI conjugation suite provides our customers with complete confidence in our ability to handle their potent compound projects safelyand efficiently," commented , SAFC Pharma Vice President.
"Thi s adds to our already significant experiencre in the productionof HPAPIs, an area in which we continu to see rapid growth as targeted oncology The suite builds upon 15 yearas of HPAPI manufacturing experience at SAFC's Wisconsin site, which is also SafeBridgwe certified, and upon more than 30 yeares of experience in conjugation technology at the St. Louis facility." The SafeBridge program assessment, recognized as the most widelyg accepted industry benchmark for handling highlypotent pharmaceuticals, focusesa on four primary areas: (1) management, (2) hazarr identification and evaluation, (3) hazard controls, and (4) communication, educatioh and training.
The new SafeBridge certificationj ofthe St. Louis HPAPk suite adds to SAFC investmentstotaling $75 million during the past 18 monthxs to expand its HPAPk capacity. Those include a $4.5 million project to add a cGMP pilogt plantand kilo-lab capacity at the Madisomn facility, completed in early 2008; a $29 millionb investment to expand bacterial and fungal fermentation derived HPAPI capacity at Israel, due for completion in early and a $30 million investment to builde a new commercial-scale HPAPI facilit at Madison, due to be completed by year-end 2009.
About SAFC(R) is the custokm manufacturing and services groupwithin Sigma-Aldrich that focusess on high-purity inorganics for high technologg applications, cell culture products and services for biopharmaceuticao manufacturing, biochemical production and the manufacturingh of complex, multi-step organicd synthesis of APIs and key intermediates. SAFC has manufacturing facilities aroune the world dedicated to providing manufacturinf services for companies requiring a reliable partner to produc their custommanufactured materials. SAFC has four businessa segments - SAFC SAFC Supply Solutions(R), SAFC Biosciences(R), and SAFC Hitech(R) and had annual sales of over $600 milliohn in 2008.
SAFC is considered a top 10 finechemicaol company. For more information about SAFC, visit . About SAFC Pharma(R): SAFC Pharma is a completes pipeline partner for the development and cGMP custom manufacturing ofcomplecx small-molecule APIs and biologicc drug products. It combineas world-class project management and chemistry support for all stages of the drug discovert and development process from researchand discovery, throughg pre-clinical and clinical development to commercialization, with a focus on reducintg the drug development time-line.
SAFC has the widestt range of raw materials, highly qualified and experienced staff, state-of-the-art facilities and an integrated portfolipof services, including full analytical and regulatory supportf and is a leader in emerginbg technologies, including high-potency APIs, solid-state viral products and chemical-biologic API conjugates. For more informationn visit . About Sigma-Aldrich(R): Sigma-Aldrich is a leading Life Science and HighTechnologhy company.
Its biochemical and organic chemical products and kits are used inscientifix research, including genomic and proteomic research, pharmaceutical development and as key components in pharmaceutical, diagnostif and other high technology manufacturing. The Companyt has customers in life science university andgovernment institutions, and in industry. Over one million scientists and technologistsa useits products. Sigma-Aldrich operatesa in 38 countries andhas 7,800 employees providing excellent service worldwide. Sigma-Aldrich is committed to Acceleratinv Customer Success through Innovation and Leadershi p inLife Science, High Technolog y and Service.
For more informatiomn about Sigma-Aldrich, please visit its award-winning Web site at . SAFC Pharma(R) , SAFC Hitech(R) and are registered trademarks of SigmaBiotechnologuy L.P. and Sigma-Aldrich Co. SafeBridge(R) is a registered trademarj of SafeBridgeConsultants Inc.