SAFC to expand high-potency API fermentation capabilities

SAFC is to invest US$29m (Euro 20.5m) to expand significantly its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel.

SAFC is to invest US$29m (Euro 20.5m) to expand significantly its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel.

The site enhancement will enable SAFC Pharma to provide process development and cGMP manufacturing to customers requiring large-scale, high-potency, toxic or hazardous drug substances (large molecule HPAPIs).

Scheduled for completion in the first quarter of 2009, the 50,000ft2 high-potency fermentation expansion will focus production on secondary metabolites, cytotoxins and large-molecule proteins. A 30,000ft2 area of the new facility has been designed to be Biosafety Level 2 compliant - enabling manipulation of human pathogens. Site capabilities include 1,000 and 4,000-litre tank capacities for bacterial and fungal fermentation.

The biologics area exploits more than 30 years of Sigma-Aldrich's expertise in research, development and scale-up of fermentation-derived products in Israel and close technology links to Israel's academic and r&d communities.

The new capabilities are expected to expand SAFC Pharma's High Potent Active Pharmaceutical Ingredient (HPAPI) offering to include fermentation-derived HPAPI manufacturing, complementing the multi-step organic synthesis flagship facility at its Madison, Wisconsin location.

"This expansion builds on the fermentation track record of our Jerusalem facility while adding significantly to our HPAPI capacity," said SAFC president Frank Wicks. "It is consistent with SAFC's strategy to extend the range and scope of coverage in niche technologies and APIs for biologics sectors."

The Israeli expansion complements recent enhancements to SAFC Pharma's biotechnology facilities in St Louis, including the 25,000ft2 cGMP purification and manufacturing facility for transgenic plant and other non-animal derived protein drug substances and its segregated partner, the 6,000ft2 purification suite for animal-derived proteins.

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