Judicial cGMP Manufacturing (Antibodies, Cell Therapies)
State-of-the-art GMP antibody and cell therapy manufacturing facility located in San Diego, CA, initially designed to be a multi-product facility for the manufacture of bulk purified proteins and monoclonal antibodies for use as therapeutics. The redesigned facility meets applicable cGMP requirements for manufacture of Phase 1 and Phase 2 Investigational New Drugs, and now includes capabilities for cellular therapies.
Aseptic Fill and Finish Contract Manufacturing Facility
As part of Sorrento core capabilities acquisitions, Bioserv, a San Diego-based cGMP contract manufacturing service organization was acquired and integrated. Facilities/cleanrooms and mature quality systems, Bioserv provides aseptic and non-aseptic fill/finish services including lyophilization for the biotechnology, pharmaceutical and diagnostic industries, as well as analytical support, labeling/kitting, stability studies and long-term controlled room temperature, cold, and frozen storage.