SAFC Pharma, under the Sigma-Aldrich (SIAL) umbrella, has added 8,000 square feet to its 44,000-square-foot Carlsbad, CA, site for two viral product manufacturing suites, to be outfitted with disposables. The addition allows for both 100-liter batch production in stirred tank bioreactors and 1,000-liter batch manufacturing in disposable bioreactors, according to an announcement.
Sigma-Aldrich announced in July a partnership agreement between its SAFC Biosciences Group and Sartorius Stedim Biotech (DIM), that combines Sartorius Stedim Biotech's (SSB) expertise in filtration and liquid handling systems with SAFC Biosciences' proficiency in development and manufacturing of cell culture media and downstream purification products.
The new space at the Carlsbad facility is for multi-lot campaigns. It includes dedicated cell expansion, bioreactor production, purification and cleanroom suites. The expansion, compliant to Biosafety Level 2, was conceived as a containment facility. It will provide clients a dedicated suite of cleanrooms for larger scale manufacturing.
The new equipment will expand the company's biologics, viral vaccine and gene therapy manufacturing to commercial-scale quantities, the company said. Facility validation studies are underway' late December is the target for start of cGMP manufacturing.
- here's the announcement