Steriles Clinical Batch Supply (Phase I, II, & III)

Working with Patheon, by Thermo Fisher Scientific, means taking advantage of a full range of fast, flexible clinical batch manufacturing services. Our years of experience, an industry-leading inspection record and our 95 percent Right First Time performance give you confidence that your therapy is prepared for success. Our integrated services also position you for the fastest and most efficient path to market in later phases.

Quality Clinical Materials to Support Your Clinical Trials

You need high-quality clinical trial materials to support clinical trials in pursuit of regulatory approval. Patheon offers fit-for-purpose formulations and processes and a comprehensive range of sterile injectable dosage forms for every development phase through approval. We can provide:

  • A broad range of phase-appropriate fill/finish equipment that ensures speed and cost-effectiveness
  • Minimal loss of precious, expensive drug product
  • Easy scalability to from early development trials to commercial scale once approved

With speed, flexibility and a full range of services, we will be responsive to your changing requirements and evolving needs as your project progresses through clinical trials. We have experience with:

  • Stainless steel and single-use manufacturing platforms
  • Filling lines fitted with various dosing pumps including peristaltic and rotary piston pumps
  • Filling of temperature and oxygen sensitive compounds
  • Controlled temperature compounding and filling
  • Low line loss filling equipment
  • cGMP batch sizes from several 100 units to several 100,000 units
  • Pre-filled syringe and cartridge assembly
  • Cold chain storage and logistics

 

Download our Sterile Dose Form Brochure.