SAFC Pharma®, a business segment of SAFC®, a member of the Sigma-Aldrich® Group (Nasdaq: SIAL), today announced the completion of an addition to its Carlsbad, Calif., facility that expands the Company's contract manufacturing services for its late phase and commercial clients.
The $12 million project includes the addition of two fully segregated state-of-the-art viral product manufacturing suites, built to employ the latest in disposable bioreactor technologies, expanding SAFC Pharma's biologics, viral vaccines and gene therapy manufacturing to commercial-scale quantities.
SAFC Pharma's Carlsbad site specializes 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 new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification and cleanroom suites. Adding 8,000 sq. ft. of manufacturing space to the existing 44,000 sq. ft. site, 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. 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 are delighted to announce this expansion of our capabilities at our Carlsbad facility, particularly when the economic environment has been so challenging," commented David Feldker, Vice President SAFC Pharma. "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."
"The expansion at our Carlsbad campus underlines SAFC's strategy to continue to invest in building world class capabilities that serve and enhance our leadership in important emerging new technologies such as niche biologics production and viral manufacturing - areas where we see great potential and traction," added SAFC President Gilles Cottier. "Our investment in large capacity manufacturing, our financial stability, experience and quality systems differentiates us in the market and enhances our abilities to securely support our customers all the way to successful product launch."
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. The Company has enjoyed a close relationship with a number of clients developing an exciting array of cancer therapeutics, gene therapies and mammalian and insect cell-based viral vaccines.
SAFC has announced worldwide investments totalling $90 million in the past two years to expand capacity for active pharmaceutical ingredients (API) production and biologic drug products. These investments build on the Company's strengths in complex emerging technologies such as high potency manufacturing and viral vaccines manufacturing, further expanding its capabilities to serve customers in these growing areas. The expansion in Carlsbad follows the acquisition in 2007 of Molecular Medicine BioServices, Inc.