Viral Vector Pre-Clinical & Clinical cGMP Fill/Finish

Our standards are high, and our aseptic fill/finish services are comprehensive. Compliance is key. Our Alachua, Florida facility 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:

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

Available services:

• 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

Question? We’re Here to Help.

Please contact us to learn more about our viral vector development and clinical services.