SAFC is investing $29 million to enhance its drug substance capabilities in high-potency biologics at the Sigma-Aldrich site in Jerusalem, Israel. In the last month, the company has reported a slew of facility expansions in Wisconsin, Ireland, and Switzerland, totaling $14.6 million.
SAFC Pharma notes that the Israel plant upgrade will allow the company to provide process development and cGMP manufacturing to customers requiring large-scale and high-potency toxic or hazardous drug substances. It is scheduled for completion in the first quarter of 2009.
The 50,000 sq. ft. high-potency fermentation expansion will focus on manufacturing secondary metabolites, cytotoxins, and large-molecule proteins. An area of 30,000 sq. ft. will be designed to be Biosafety Level 2 compliant, enabling manipulation of human pathogens. Site capabilities include 1,000 L and 4,000 L tank capacities for bacterial and fungal fermentation.
These capabilities will enable SAFC Pharma to offer fermentation-derived high-potentcy API manufacturing, according to the company. The revamped Israel site will complement the multistep organic synthesis flagship facility at Madison, WI, as well as the biotechnology facilities in St. Louis, MO.