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SAFC To Add API Conjugation Suite

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By: Tim Wright

Editor-in-Chief, Contract Pharma

SAFC, a member of the Sigma-Aldrich Group, plans to begin construction of a new cGMP potent active pharmaceutical ingredients (APIs) conjugation suite at its St. Louis manufacturing site. This addition will support oncology drug substance requirements for a combination of small molecule chemistry, containment engineering, highly regulated biologics manufacturing and extensive quality control capabilities.

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 anti-cancer market. The new 600-sq.-ft. conjugation suite, expected to be operational in late 2007, will be SafeBridge certified and will 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, said, “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.”

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