PacificGMP is a Contract Research, Development and Manufacturing Organization

that specializes in single-use technology for the development and production of biopharmaceuticals for Phase I and Phase II clinical trials.

PacificGMP was acquired by Abzena plc on Sep 14, 2015. See press release.

cGMP and non-cGMP Services

PacificGMP provides an array of development and production services for recombinant proteins, antibodies, cell therapies and vaccines for preclinical and clinical materials.

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Process Development

PacificGMP excels at upstream and downstream process development.

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Regulatory Affairs Compliance

Our staff is well-versed in the guidelines of current Good Manufacturing Procedures.

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PacificGMP is a leader in the application of single-use bioprocessing technology. Learn more

What We Do

1. Develop & Manufacture Proteins

We work with our clients in developing and manufacturing proteins, including monoclonal antibodies and recombinant proteins. We develop and adapt cell lines, generate upstream and downstream processes, and manufacture under GLP for toxicology studies and standard reference material.

2. Provide Services

PacificGMP’s core services focus on 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. 

3. Create Documentary Packages

As an integral part of manufacturing under GMP standards, PacificGMP creates document packages sufficient to meet the requirements facing organizations in obtaining regulatory approval of drug product used in human clinical trials. PacificGMP generates with its partners the Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug (“IND”) applications.

PacificGMP team members are experts in single-use technology for bioprocessing, clinical material production and upstream and downstream processing.

Our 1,300 square meter facility, located in San Diego, California, houses research, development and analytical labs, as well as Class 10,000 and Class 100,000 manufacturing suites.

Get the latest PacificGMP news and events information here.

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