• Specialize in development and manufacturing of biologics
  • Exclusively utilize single-use technology
  • Expertise in process design, development and scale-up, preclinical and clinical manufacturing
  • On-site training in the use of single-use bioreactors and components
  • Located in San Diego, California - "Biotech Beach"


Services

cGMP and non-cGMP Services

PacificGMP provides an array of cGMP and non-GMP production services for proteins and antibodies, gene therapy and vaccine products for preclinical and clinical materials. Our technology and expertise allow for rapid turnaround times and the most cost effective solutions in the industry.

To learn more about our custom services click here.

Process Development

PacificGMP excels at upstream and downstream process development. Process development services can stand alone or be integrated into preclinical and clinical manufacturing projects. PacificGMP focuses on improving yield at each stage of development by optimizing each step in the process.

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Regulatory Affairs Compliance

PacificGMP specializes in antibody, recombinant protein, gene therapy and vaccine product production. Our staff is well-versed in the guidelines of current Good Manufacturing Procedures (cGMP - see 21CFR210-211), in particular as they apply to the manufacture of biologic agents (see 21CFR600-680), as well as Good Tissue Practices (GTP - see 21CFR1270-1271). PacificGMP also adheres to international GMP requirements as set forth by the International Conference on Harmonization guideline Q7A and related documents.

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Training Courses

PacificGMP and GE Healthcare Wave Products Group are pleased to announce the nation's first hands-on disposable bioprocessing training program. Featuring the latest Wave equipment, we offer practical instruction and hands-on production experience in the set-up, the transition to and the use of single-use bioprocessing systems.

To learn more click here.