Comprehensive cGMP fill/finish for cell and gene therapy

Our standards are high, and our aseptic fill/finish services are comprehensive. Compliance is key. Our Alachua, Cambridge and Lexington facilities and processes are designed to be compliant for viral vector-based gene therapy products under the FDA Code of Federal Regulations (Part 21) and the European Advanced Therapy Medicinal Products’ regulations.

Semi-automated fillings solutions include:

  • SKAN Isolator technology with fully integrated VHP—Grade A in Grade C suites
  • Bausch + Ströbel vial filling line—up to 1000 vials

Available services include:

  • Formulation and compounding development
  • Standard, pre-qualified vial configurations available:
    • 0.25 to 10 ml fill volumes
    • 0.5 to 10 ml vials (glass and Crystal Zenith® plastic)
  • 100% visual inspection
  • Primary labeling and packaging

Download this white paper to get a better understanding of the evolving regulatory guidelines for cell and gene therapies.

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Learn more about our viral vector cGMP fill/finish services.

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