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SAFC Pharma Expands Facility to Bolster Biologics Manufacturing
SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics.
SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification, and cleanroom suites.
The $12-million project includes the addition of two fully segregated viral product manufacturing suites, built to use the latest in disposable bioreactor technologies. This expansion will expand SAFC Pharma's biologics, viral vaccines, and gene therapy manufacturing to commercial-scale quantities.
The company has added 8,000 sq. ft. of manufacturing space to the existing 44,000 sq. ft. site, which will enable both 100-L batch production in stirred-tank bioreactors and 1,000-L batch manufacturing in disposable bioreactors. Designed from the outset as a containment facility, the expansion space will allow clients to secure a dedicated suite of cleanrooms for large-scale manufacturing.
Facility validation studies are currently underway for the additional suites, with an expected start of cGMP manufacturing operations by the end of December 2009.