News

Posted On: 01/17/2008

SAFC Pharma to Expand Biologics Manufacturing Capacity

PharmaManufacturing.com

St. Louis, Mo.-based SAFC, a member of the Sigma-Aldrich Group, on Jan. 14 announced its plans for a $12 million expansion at its niche biologics production facility in Carlsbad, Calif. Two new fully segregated state-of-the-art viral product manufacturing suites will be built to employ the latest in disposable bioreactor technologies and enable SAFC Pharma’s viral manufacturing to increase to commercial-scale quantities.

Due to become operational in the second half of 2009, 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. The expansion will add to the current 44,000-sq.-ft. site and 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."

SAFC Pharma develops and manufactures complex small-molecule active pharmaceutical ingredients (API) and biologic drug products for the pharmaceutical and biopharmaceutical industries. This latest facility expansion follows a series of 2007 investments for SAFC Pharma, which includes a $10 million expansion of commercial-scale APIs manufacturing and storage capacity, respectively, at Arklow, Ireland and Buchs, Switzerland, 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 flagship high-potency facility in Madison, Wis. and a new high-potency API conjugation suite located at the St. Louis manufacturing campus, both scheduled for completion in the first quarter of 2008. For more information about SAFC, visit www.safcglobal.com.