SAFC Pharma has completed the addition to its Carlsbad, California facility that expands the company’s contract manufacturing services for its late phase and commercial clients.
The $12m project includes the addition of two fully segregated viral product manufacturing suites, built to employ indisposable bioreactor technologies, expanding SAFC Pharma’s biologics, viral vaccines and gene therapy manufacturing to commercial-scale quantities.
Reportedly, SAFC Pharma’s Carlsbad site specialises in the process development and manufacturing of viral vaccines and viral therapeutics, including a full menu of support services, from preclinical process and analytical development to final fill/finish and commercial bulk drug supplies.
The company said that the new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification and cleanroom suites. The addition enables both 100-liter batch production in stirred tank bioreactors and 1,000-liter batch manufacturing in disposable bioreactors, and is Biosafety Level 2 compliant, allowing manipulation of human pathogens.
Reportedly, the facility validation studies are currently underway, with an expected start of cGMP manufacturing operations by the end of December 2009. The site added numerous utility support systems to allow for continuous operation and will now utilize its new Water For Injection (WFI) system.
Moreover, SAFC has announced worldwide investments totalling $90m in the past two years to expand capacity for active pharmaceutical ingredients (API) production and biologic drug products.The expansion in Carlsbad follows the acquisition in 2007 of Molecular Medicine BioServices.
David Feldker, vice president at SAFC Pharma, said: “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. 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.”