Regulatory Compliance

Good Manufacturing Practices & Good Tissue Practices

Abzena specialises in the development and manufacture of recombinant proteins, antibodies, conjugates, gene therapy products, and cellular therapies. Our staff are well versed in the guidelines of cGMP in particular as they apply to the manufacture of biologic agents as well as Good Tissue Practices.

Abzena also adheres to GMP requirements as set forth by the FDA guidelines for phase I and II clinical products 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
  • Abzena offers a wide range of services and advice to assist clients in matters of regulatory compliance including:
    • Developing a strategy for the stepwise development of manufacturing scale and product characterisation appropriate to the stage of product development
    • Assistance in preparation of regulatory filings
    • Assay development for analysis of product for preclinical and clinical use

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