Clinical Trial Supply

PMI Bio offers solutions to your early phase clinical trial needs. Our capabilities are in bulk liquid and bulk semisolid (creams, gels, ointments, etc.) manufacturing, aseptic fill and finish and manual non-aseptic fill and finish. Our manufacturing methods range from general mixing to particle size reduction. We specialize in high-pressure microfluidization for small to medium scale batches. Our goal is to provide the highest quality of products and services to support the needs of our clients.

Aseptic Manufacturing

At PMI Bio our goal is to offer cost-effective and flexible solutions to your aseptic fill and finish needs for pre-clinical and phase I / II clinical trial supply. Our dedicated team applies relevant good manufacturing practices to all manufacturing activities assuring the safety, identity, strength, purity, and quality of drug products produced at our site. Our facility meets FDA and EU requirements with 1000 ft2 of ISO 5-7 aseptic processing space. We utilize Flexicon FPC50 Automated fill equipment surrounded by an open Restricted Access Barrier system for contamination control. Filled product goes through our 100% manual visual inspection process by our highly trained and qualified team in compliance with applicable regulations.

Aseptic Fill and Finish Capabilities

  • Filling, full stoppering of injection stoppers, and crimp capping
  • Sterile Liquid Parenteral dosage form
  • Aseptic Filling of Liquid Oral dosage form
  • 13 mm or 20 mm Injection Stoppers and Flip-off or Aluminum Cap Sizes
  • 1 mL to 100 mL Vials
  • 16 mm to 52 mm container diameter
  • Gas purge and overlay
  • Up to 25 vials per minute
  • 100% Manual Visual Inspection

Non-Sterile Manufacturing

We offer 1800 ft2 of ISO 8 manufacturing space for buffer preparation and compounding of Liquid Parenteral, Liquid Oral, Liquid Topical, and Semisolid Topical dosage forms. Our facilities and equipment are fully qualified for the intended use. We specialize in microfluidization using two DeBEE 2000-30-3.4 pilot scale high-pressure homogenizers. Our technology transfer approach seamlessly adopts and implements your processes or our own processes developed by our process development department.

Non-Sterile Capabilities

  • Bulk Liquid Parenteral batch sizes of 5 L to 80 L
  • Bulk Liquid Oral batch sizes of 5 L to 80 L
  • Liquid Topical batch sizes of 5 L to 80 L
  • Semisolid Topical batch sizes of 10 kg to 20 kg

Labeling and Kitting

We have a dedicated IPL room for 100% manual visual inspection, an automated label machine, and packaging.

Labeling

Our automated label machine is capable of handling labels up to 9” wide along with a variety of standard vial and round bottle sizes ranging from 5 mL up. We also offer manual labeling to meet the needs of your project.

Packaging

We work with you to offer customized packaging solutions with options of single, double, or multi-cell cartons or cases.

Kitting

We provide kitting solutions to your preclinical and clinical trial needs and can ship directly to the clinical trial sites or requested destinations.

Capabilities and Capacity

  • FDA and EU GMP Certified Facility
  • Pre-clinical, Phase I and Phase II
  • Aseptic Fill and Finish
    • 1000 ft2 of ISO 5-7 Aseptic Processing space
    • Liquid Parenteral Dosage Form
    • Liquid Oral Dosage Form
  • Non-Sterile Manufacturing
    • 1800 ft2 of ISO 8 Manufacturing area
    • Microfluidization Technology
    • Buffer Preparation
    • Bulk Liquid Parenteral – 5 L to 80 L
    • Bulk Liquid Oral – 5 L to 80 L
    • Liquid Topical - 5 L to 80 L
    • Semisolid Topical – 5 kg to 20 kg
  • Labeling and Kitting
    • Automated or Manual Labeling
    • Customized Packaging Solutions
    • Preclinical and Clinical Trial Kitting