SAFC(R), a member of the Sigma-Aldrich(TM) Group, has announced its plans to begin construction of a new cGMP potent active pharmaceutical ingredients (APIs) conjugation suite at its Pharma sector's St. Louis manufacturing campus. This addition is expected to support oncology drug substance requirements that demand a combination of small molecule chemistry, containment engineering, highly-regulated biologics manufacturing and extensive Quality Control capabilities.
Focused on the oncology drug niche, the new suite will enable the conjugation of highly potent active pharmaceutical ingredients (HPAPIs) to a variety of targeted delivery molecules, including monoclonal antibodies, for the fast-growing anti-cancer market. The new 600 sq. ft conjugation suite, expected to be operational in late 2007, will be SafeBridge(R) certified and can accommodate early-stage clinical supplies of potent conjugated APIs, with capabilities to expand production into commercial-scale, handling multi-Kg quantities of conjugated HPAPIs per batch.
SAFC President, Frank Wicks, commented, "High potency conjugation is an exciting new technology that demands a very special combination of specific skills. Adding HPAPI conjugation capacity enables SAFC to further vertically integrate our contract manufacturing services to pharmaceutical companies that are developing novel cures for cancer. SAFC is a leading producer of many small molecule HPAPIs and has been performing non-potent conjugations for over 30 years. Adding specialized high-containment biologic capacity for performing potent conjugations was a logical extension to our business."
This investment is in addition to SAFC's recently announced plans to add HPAPI assets in the U.S. and Israel, and is the third in a sequence that markedly enhances SAFC's capacity and capabilities in HPAPI manufacturing. These plans include the $4.5 million expansion to introduce additional cGMP pilot plant and kilo lab capacity at the Safebridge-certified SAFC Madison, Wisconsin facility and its $12 million, 38,000 sq. ft. expansion program that was completed in 2006. The second HPAPI-focused development is the $29 million investment planned to expand fermentation capacity at the Sigma-Aldrich Jerusalem, Israel facility, due for completion in 2009.
SAFC Pharma is focused on cGMP manufacturing, process development and contract services for small organic APIs and advanced intermediates, and the development of large molecule biopharmaceuticals.