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