Sterile Commercial Manufacturing

Thermo Fisher Scientific offers experience, reliability – and a very broad range of sterile fill/finish commercial capabilities. We have an enviable record of steriles commercialization success for our clients. No CDMO has more sterile injectable new drug application (NDAs) than we do: from 2006-2017, we helped our clients earn 26 NDA approvals for sterile injectables.

Thermo Fisher Scientific is a global leader in contract pharmaceutical manufacturing. With us as your partner, you’ll have access to extensive commercial capabilities, scale and capacity; a broad spectrum of sterile dosage forms; and a global network of fully integrated world-class facilities – all with approvals from international regulatory agencies and Right First Time/On-Time track records that are second to none. Our capabilities span:

 

Why Thermo Fisher Scientific?

Our groundbreaking custom manufacturing suites and streamlined supply chain solutions are transforming the industry. Over 40 years, quality and innovation have earned our team the trust of the industry:

  • All of the top 20 pharma companies
  • 15 of the top 20 specialty pharma companies
  • 18 of the top 20 biotech companies

Sterile Injectables Development & Manufacturing Capabilities

We offer extensive sterile injectables development and manufacturing capabilities at all scales. This includes specialized expertise in liquid-filled and lyophilized vials. You’ll also have access to state-of-the-art, cGMP manufacturing capabilities for prefilled syringes and cartridges. Disposable (single-use) manufacturing technologies as well as traditional stainless steel equipment are available.

Flexibility, speed, expertise, and experience are needed to advance your sterile injectable drug products from the preclinical phase to approval. Let us help you transform your discovery into a drug product with the best chance for approval by leveraging:

  • Flexible approaches to maximize speed and cost
  • Proven technology transfer experience
  • Scalability to commercial manufacturing
  • Strong regulatory track record

 

Sterile Manufacturing Dose Forms

We offer a broad range of capabilities to address the specific needs of your drug product including the following sterile dose forms:

  • Small-volume parenterals
  • Large-volume parenterals
  • Liquid filled vials
  • Lyophilized vials
  • Extensive range of vial sizes including ISO standard vials
  • Pre-filled syringes
  • Pre-filled cartridges

Find out which of our Sterile Manufacturing Sites may be right for your project.