SAFC to build new potent API conjugation suite

Published: 5-Oct-2007
Ingredients

SAFC, a member of the Sigma-Aldrich Group, is to begin construction of a new cGMP potent active pharmaceutical ingredients (APIs) conjugation suite at its St Louis manufacturing campus.


SAFC, a member of the Sigma-Aldrich Group, is to begin construction of a new cGMP potent active pharmaceutical ingredients (APIs) conjugation suite at its 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. 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 anticancer market.

The new 600ft2 conjugation suite, which is expected to be operational in late 2007, will seek SafeBridge certification 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.

"High potency conjugation is an exciting new technology that demands a very special combination of specific skills," said SAFC president Frank Wicks. "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 more than 30 years. Adding specialised 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 US and Israel. These plans include the US$4.5m (Euro 3.19m) expansion to introduce additional cGMP pilot plant and kilo lab capacity at the Safebridge-certified SAFC Madison, Wisconsin facility and its $12m (€8.5m), 38,000ft2 expansion programme that was completed in 2006.

The second HPAPI-focused development is the $29m (€20.5m) investment planned to expand fermentation capacity at the Sigma-Aldrich Jerusalem facility, due for completion in 2009.

  • Companies:
  • Merck Group
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