SAFC Pharma, a business segment of SAFC®, a member of the Sigma-Aldrich® Group (NASDAQ: SIAL), announced the completion of a $12M expansion to its Carlsbad, Calif. manufacturing facility, which will scale-up its commercial output capacity for viral vaccines, biologics and sophisticated gene therapy solutions.
The new facility expansion includes two stand-alone suites utilizing the latest in disposable bioreactors, streamlining production workflows and reducing the overall drug development window for its clients. This facility will specialize in developing and manufacturing viral therapeutics and vaccines. Designed specifically for multi-lot campaigns and offering cleanroom, bioreactor production, purification and dedicated cell expansion, this 18% addition to the overall size of the facility enables larger-scale production via an advanced and more efficient pipeline. The Carlsbad installation can now easily handle 100 and 1,000-liter batch production under Biosafety Level 2 requirements, which means they can work with human pathogens, and its design allows clients to secure a dedicated cleanroom for large-scale production.
Vice President of SAFC Pharma, David Feldker, was pleased to announce his company’s increased capacity as a result of this expansion, pointing to its success as evidence of SAFC Pharma’s health even during this challenging economic environment. Feldker indicated strong market cap potential with customers in late clinical phase that lacked in-house manufacturing capability, and that even those with such capability could leverage his company’s superior process, workflows, and output capacity. Feldker said of such clients that they would generate a “great deal of value in the biologics and viral manufacturing marketplace in the next three to five years.”
SAFC Pharma is a drug development company which specializes in providing the pharmaceutical and biopharmaceutical sector with a “single point of contact” solution to drug manufacturing. When it comes to commercializing the latest in standard and high-potency, small-molecule, Active Pharmaceutical Ingredients (API’s), SAFC Pharma is there to provide world-class management and cGMP custom manufacturing. Validation studies for the expansion are currently in progress, with cGMP status slated for December 09.
With its certified processes and procedures, supporting all stages of commercial drug development, SAFC Pharma has several state-of-the-art facilities worldwide, allowing it to satisfy customer demands and offer the full spectrum of related services. With over $90M in investments worldwide SAFC is ramping up global capacity for API production and other biologics products, reinforcing a dominant footing in emergent biotech manufacturing.