Timely delivery of high-quality investigational drug products is key for the success of your trial. Rely on your dedicated PMI Bio team for flexible, cost-effective solutions to your aseptic fill and finish needs. Our GMP manufacturing facility for preclinical and Phase I and II trial materials complies with FDA and EU regulations and includes 1,000 square feet of ISO 5-7 aseptic processing space.

To maintain purity, our Flexicon FPC50 automated fill equipment is surrounded by a restricted-access barrier (RAB) system. Ultimately, filled product undergoes a 100% manual visual inspection by our highly qualified team. Our aim is to ensure the safety, identity, strength, purity, and quality of aseptic materials for your clinical trial.

Aseptic Fill and Finish Capacity and Capabilities

  • ISO 5-7 aseptic processing space
  • Aseptic filling of liquid drug products
  • 2 mL to 100 mL vials
  • Up to 25 vials per minute
  • Gas purge and overlay
  • 100% manual visual inspection

“Beginning with your knowledge of your drug product, we draw on our industry experience and expertise to tailor fill and finish services that fit your exact needs.”

Drew Simmons

BS in Biology

  • Leads cGMP fill/finish services
  • 6 years of experience leading bulk drug production and aseptic fill/finish services of small molecule parenteral, semi-solid, and liquid products; also experienced in scale-up development and formulations
  • Specialties: Process design and development, aseptic filling, visual inspection, packaging, and labeling
  • Passions: Household DIY projects, outdoor sports, and the Nashville music scene