Judicial Manufacturing (Antibodies, Cell Therapies)
State-of-the-art cGMP 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 antibodies for use as therapeutics. The redesigned facility meets applicable cGMP requirements for manufacture of Investigational New Drugs, and now includes capabilities for cellular therapies.
Bioserv Aseptic Fill and Finish Contract Manufacturing Facility
Now part of Sorrento’s core capabilities, Bioserv, a cGMP contract manufacturing service organization was acquired and integrated. With 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 labeling/kitting and long-term controlled room temperature, cold and frozen storage.
Camino Santa Fe Oncolytic Virus Production Facility
Sorrento’s viral production facility includes process development and analytical testing laboratories as well as cGMP clean rooms. Operations supported include cell culture, purification, fill and finish processes as well as analytical assay development and quality control testing. The facility is licensed by the CA Food and Drug Branch and has successfully manufactured drug substances and drug products for pre-clinical, PHASE I and PHASE II clinical trials.
ADC Conjugation, Payload and Linker Synthesis Facility
Sorrento operates its cGMP facility for Antibody Drug Conjugate (ADC) production in Suzhou, China, under the Levena Biopharma brand name. The site has been in operation since 2016 and can support clinical cGMP production of drug linkers as well as antibody conjugation. With full analytical support capabilities and a facility equipped to handle highly potent API (isolator), the site has supported over 20 clinical batches for clinical trials worldwide.
Sofusa Research and Manufacturing Facility
SOFUSA manufacturing capabilities in Atlanta, GA include precision nanofabrication techniques alongside assembly and testing of device components. The operation is able to support manufacturing of custom devices to support both preclinical studies and Phase I and II clinical trials. In addition, the SOFUSA research center is a fully functional small animal lab with state-of-the-art imaging capabilities (NIRF, IVIS, PET-CT) to fully characterize the impact of lymphatic delivery relative to traditional injections and infusions.