ST. LOUIS, Oct. 2 /PRNewswire-FirstCall/ -- SAFC(R), a member of the Sigma-Aldrich(TM) Group (Nasdaq: SIAL), 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 spec
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