SAFC Pharma to increase viral product manufacturing capacity

SAFC, a member of the Sigma-Aldrich group, is to build a US$12m (Euro 8.3m)expansion at its niche biologics production facility in Carlsbad, California.

SAFC, a member of the Sigma-Aldrich group, is to build a US$12m (Euro 8.3m)expansion at its niche biologics production facility in Carlsbad, California.

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 8,000ft2 of manufacturing space and enable 100 litre batch production in stirred tank bioreactors and 1,000 litre batch manufacturing in disposable bioreactors. The expansion will add to the current 44,000 ft2 site and be Biosafety Level 2 compliant, allowing manipulation of human pathogens.

"The 2007 acquisition of Molecular Medicine Bioservices significantly enhanced SAFC Pharma's biologics offer in viral product manufacturing, including novel vaccines and gene therapies," said SAFC Pharma vice president of manufacturing and US operations, David Feldker. "This expansion will increase our Carlsbad site capabilities from clinical-scale to commercial-scale manufacturing, further demonstrating SAFC's continued commitment to the development and manufacturing of complex chemistries and niche biologics."

This latest facility expansion follows a series of investments in 2007 for SAFC Pharma, which includes a $10m (€6.9m) expansion of commercial-scale APIs manufacturing and storage capacity, respectively, at Arklow, Ireland, and Buchs, Switzerland, and a $29m (€20m) potent-fermentation expansion in Jerusalem, Israel.

Other investments include a $4.5m (€3.1m) cGMP pilot plant and kilo lab capacity expansion at the company's flagship high-potency facility in Madison, Wisconsin, 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.

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