SAFC Pharma Expands Facility to Bolster Biologics Manufacturing
SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics.
SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification, and cleanroom suites.
The $12-million project includes the addition of two fully segregated viral product manufacturing suites, built to use the latest in disposable bioreactor technologies. This expansion will expand SAFC Pharma's biologics, viral vaccines, and gene therapy manufacturing to commercial-scale quantities.
The company has added 8,000 sq. ft. of manufacturing space to the existing 44,000 sq. ft. site, which will enable both 100-L batch production in stirred-tank bioreactors and 1,000-L batch manufacturing in disposable bioreactors. Designed from the outset as a containment facility, the expansion space will allow clients to secure a dedicated suite of cleanrooms for large-scale manufacturing.
Facility validation studies are currently underway for the additional suites, with an expected start of cGMP manufacturing operations by the end of December 2009.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
