PacificGMP specializes in the development and manufacture of antibodies, recombinant proteins, cell therapies and vaccine products. 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.
cGMP compliance is maintained through a combination of:
- Working with clients to develop robust manufacturing processes
- Ongoing training of manufacturing and support staff
- Proper design, maintenance and monitoring of manufacturing facility and equipment (IQ, OQ, PQ validation)
- QA/QC oversight throughout the process
PacificGMP offers a wide range of services and advice to assist clients in matters of regulatory compliance, including:
- Strategizing the stepwise development of manufacturing scale and product characterization, appropriate to the stage of product development
- Assistance in preparation of regulatory filings (e.g., Chemistry, Manufacturing & Controls)
- Assay development for preclinical, clinical use:
- Product detection
- Product characterization
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