SAFC Pharma began operations at its 7,000-sq.-ft. state-of-the-art lab complex in Carlsbad, CA. The new lab, located next to the company's viral substance production facility, support SAFC Pharma's biologics offering for pharmaceutical and biotechnology customers, and complements its existing portfolio of biologics capabilities with process improvement, technology transfers of processes and assays, and characterization of active ingredients.
The new complex includes a dedicated Polymerase Chain Reaction (PCR) facility, a tissue culture lab and stability suite supported by microbiology and regular testing labs, and a Quality Control (QC), Process Development (PD), assay development and validation scientific team. The PCR facility has separate suites with uni-directional personnel flow for sample processing, reaction assembly and PCR amplification. The unit is also capable of performing cell-based, molecular and immunological assays, as well as analytical assays such as HPLC. All suites are equipped for independent air handling with air pressure gradients to prevent cross-contamination, according to the company.
On-site QC functions will include environmental monitoring and microbiology, stability, product and raw materials release, and analysis of in-process samples. All standard operating procedures and protocols are designed to adhere to cGMP guidelines.
SAFC president Gilles Cottier stated, "Our investment in this world-class facility at our Carlsbad campus underlines SAFC's continued commitment to building capabilities in important emerging new technologies such as viral vaccines and gene therapies — areas where SAFC sees great potential. As new and increasingly complex products make their way to commercialization, SAFC will continue to be strongly positioned to collaborate fully with its partners and customers on the development and production of treatments for cancer, cardiovascular and central nervous system diseases."