The OCTC and PacificGMP have entered into a co-marketing relationship to employ PacificGMP’s contracting and biopharmaceutical development services with OCTC’s study, site, and core lab services.
PacificGMP works with clients in developing and manufacturing biologics, including monoclonal antibodies, recombinant proteins, vaccines, gene therapy and cell therapy products. We develop and adapt cell lines, develop upstream and downstream processes, and manufacture under GLP for toxicology studies as well as standard reference material.
PacificGMP’s core services revolve around GMP manufacturing for human usage. We manufacture master cell banks and drug substances and drug products under cGMP standards for human clinical trials, development and qualification of release assays, fill/finish of drug product, oversight of necessary third party vendors and advising on regulatory matters. We also manufacture under cGMP, proteins for commercial, non-therapeutic purposes.
The premier biologics contract development and manufacturing organization utilizing single-use flexible technology throughout the manufacturing process
PacificGMP’s mission is to provide the highest quality, flexible solutions for its customers bioprocessing needs
Facility licensed by the California Department of Public Health Food and Drug Branch (FDB) and registered with the US Food and Drug Administration (FDA)
- Cell line, process development and manufacturing services to drug developers involved in preclinical and Phase 1-2 clinical projects
- Utilize single-use flexible technology throughout the manufacturing process, enabling more timely and cost-effective production than traditional re-usable CMOs
- PacificGMP values its clients first and foremost and is committed to exceeding each client’s expectations
- PacificGMP lead scientists have 100+ years of combined biopharmaceutical industry experience with numerous drug development projects from product R&D through cGMP manufacture.
- Additional extensive experience in project management, technology transfer, Quality, Regulatory, process and assay validation.
PacificGMP provides an array of cGMP and non-GMP production services for recombinant proteins, antibodies, conjugates, gene therapy, vaccine and cell therapy products for preclinical and clinical materials. Our expertise in employing single-use technology allows for rapid turnaround times and the most cost effective solutions in the industry.
Projects include such diverse activities as cell line development and optimization, upstream production and downstream purification process development, scale-up, manufacturing, and fill/finish. Our track record is solid: We deliver high quality products on budget and on time.
Our team’s core upstream expertise includes cell line creation and development; cell line cloning, amplification and optimization; growth media optimization; and development of conditions and strategies to improve production, viability, recovery and scalability. Downstream capabilities include development and scaling of processes, resin screening, flow rate optimization, dynamic binding capacity optimization, purification, filtration, antibody conjugation and viral clearance validation. Additionally, product characterization, analytical testing and document writing (development reports, protocols, and batch records) are routinely performed.
- Licensed by California FDB and registered with the US FDA
- Over 30 successful site audits
- 14000 ft2 state-of-the-art facility
- ISO Class 5, ISO Class 7, ISO
- Class 8 Controlled Environments
- Multiple manufacturing production suites
- Development laboratories
- Quality control/Analytical laboratories
- Fill & finish suite
- Internal clean room expansioncapabilities