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