SAFC Pharma, a focus area within SAFC, a member of the Sigma-Aldrich Group , recently announced details of a new suite that has been commissioned at its St. Louis campus that will produce high-potency active pharmaceutical ingredient (HPAPI) conjugates to support oncology drug development. The 600-sq ft suite will enable the conjugation of HPAPIs to a variety of targeted delivery molecules, including monoclonal antibodies. In addition, the new facility can accommodate early-stage clinical supplies and can handle multi-kilogram quantities, with the capability to expand production up to commercial-scale.
"Bio-conjugates represent the next generation of 'smart munitions' in healthcare's anti-cancer arsenal," said Dave Feldker, SAFC Pharma US Vice President. "Due to our significant breadth of chemistry, containment engineering and biologics capabilities, SAFC Pharma is well-positioned as the leading player in this exciting niche."
SAFC has significant experience and capacity in the production of HPAPIs, an area in which the company is seeing rapid growth. The company's Madison facility, for example, has produced HPAPIs for more than 15 years and is certified by SafeBridge Consultants for handling HPAPIs up to Category IV (the most potent) while the St. Louis site has more than 30 years experience in conjugation technology.
"The HPAPI market has grown at a high double-digit pace; the number of customers we have has more than doubled over the past three years, with particular demand growth for biologic-HPAPI conjugates for oncology drugs," continued Dave Feldker. "Dozens of products are currently in clinical trials, and this new facility underline's SAFC's intent to support growth in this niche, strengthening our position as the leading pipeline partner for the pharmaceutical and biopharmaceutical industry."
SAFC has announced investments totaling $75M during the past year to expand HPAPI capacity. Those include a $4.5M project to add a cGMP pilot plant and kilo-lab capacity at Madison, completed earlier this year; a $29-M investment to expand bacterial and fungal fermentation derived HPAPI capacity at Jerusalem, due for completion in 2009; and a $30-M investment to build a commercial-scale HPAPI facility at Madison, due to be completed by year-end 2009.
SAFI 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 focus areas - SAFC Pharma, SAFC Supply Solutions, SAFC Biosciences, and SAFC Hitech - and had annual sales of nearly $600 million in 2007. SAFC is one of the world's 10 largest fine chemical businesses. For more information, visit www.safcglobal.com.
Sigma-Aldrich is a leading Life Science and High Technology company. Its biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical 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 36 countries and has 7,900 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through 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.