SAFC to Expand Manufacturing Capacity

SAFC, a member of the Sigma-Aldrich group, has plans for a $12 million expansion at its biologics production facility in Carlsbad, CA. Two new, separate state-of-the-art viral product manufacturing suites will employ the latest in disposable bioreactor technologies and enable the company’s viral manufacturing to increase to commercial-scale.

The new suites will add 8,000 sq. ft. of manufacturing space and enable 100 L batch production in stirred tank bioreactors and 1,000 L batch manufacturing in disposable bioreactors and will become operational in the second half of 2009. The expansion will add to the current 44,000-sq.-ft. site and will be Biosafety Level 2 compliant, allowing manipulation of human pathogens.
   
SAFC Pharma vice president of manufacturing and U.S. operations David Feldker commented, “The 2007 acquisition of Molecular Medicine Bioservices significantly enhanced SAFC Pharma’s Biologics offer in viral product manufacturing, including novel vaccines and gene therapies. This expansion will increase our Carlsbad site capabilities from clinical-scale to commercial-scale manufacturing, further demonstrating SAFC’s continued commitment to support its customers in the development and manufacturing of complex chemistries and niche biologics.”
   
This facility expansion is part of a series of investments, which includes a $10 million expansion of commercial-scale APIs manufacturing and storage capacity at Arklow, Ireland and Buchs, Switzerland, respectively, and a $29 million potent-fermentation expansion in Jerusalem, Israel. Other investments include a $4.5 million cGMP pilot plant and kilo lab capacity expansion at the company’s high potency facility in Madison, WI and a new high-potency API conjugation suite at the St. Louis manufacturing campus, both scheduled for completion in 1Q2008.