SAFC Pharma has reported the completion of an addition to its Carlsbad, CA, facility that expands its contract manufacturing services for its late-phase and commercial clients. The $12 million project includes the addition of two fully segregated viral product manufacturing suites built to employ the latest in disposable bioreactor technologies.
SAFC Pharma's Carlsbad site specializes in the process development and manufacturing of viral vaccines and viral therapeutics, including preclinical process and analytical development to final fill/finish and commercial bulk drug supplies. The latest expansion, designed for multilot campaigns, includes dedicated cell expansion, bioreactor production, purification, and cleanroom suites.
The new 8,000 sq. ft. of manufacturing space on top of the existing 44,000 sq. ft. site enables both 100 L batch production in stirred tank bioreactors and 1,000 L batch manufacturing in disposable bioreactors. It is biosafety level 2 compliant, allowing manipulation of human pathogens. Designed from the outset as a containment facility, the expansion space allows clients to secure a dedicated suite of cleanrooms for larger scale manufacturing.
“We expect to see a great deal of value in the biologics and viral manufacturing marketplace in the next three to five years generated by two main customer types: those with late clinical-phase opportunities but without any in-house manufacturing capability and those with late clinical-phase opportunities that have some manufacturing capabilities but may be seeking an additional safety net or wish to avoid additional capital expansion until their technology and drug has proven itself,” says David Feldker, vp SAFC Pharma. “By adding and extending our capabilities at Carlsbad, we are providing customers with an attractive, clear pathway that adds value and supports secure, successful product launches."
Facility validation studies are currently under way, with an expected start of cGMP manufacturing operations by the end of December. The site added numerous utility support systems to allow for continuous operation and will now utilize its new water for injection system.
Over the past two years SAFC has said that it would invest about $90 million to bolster production capacity for APIs and biologics. The expansion in Carlsbad follows the acquisition in 2007 of Molecular Medicine BioServices.