Sterile Commercial Capabilities

Come to Thermo Fisher Scientific for our proven record of steriles commercialization success.

We have unmatched experience, reliability and flexibility—offering a broad range of sterile fill/finish commercial capabilities. From 2006-2017, we helped our clients earn 26 new drug application (NDA) approvals for sterile injectables—more than any other CDMO.

Let our experts help with your project.  

More Sterile NDAs Than Any Other CDMO

With more than 20 years of experience in sterile injectables commercial production, including more than 240 biologic products, we know how to deliver.

We provide access to extensive sterile pharmaceutical development and manufacturing capabilities at all scales, including liquid-filled and lyophilized vials.

We also offer state-of-the-art commercial-scale cGMP manufacturing for prefilled syringes and cartridges. Disposable (single-use) manufacturing technologies as well as traditional stainless steel equipment are available.

Our capabilities include:

Our sterile capabilities also include process development and manufacturing of biologic drug substances at scales from clinical to global commercial. With Thermo Fisher Scientific as your single-source partner, you’ll be able to bring your discoveries to market with more speed and efficiency than ever before.

Sterile Injectables

Liquid-Filled Vials
  • Aseptic Filling, Terminal Sterilization when required.
  • Extensive range of vial sizes, including ISO standards.
  • Batch sizes to meet product demand.
  • Disposable (single-use system) manufacturing options.
  • Glass or polymeric vials available.
Lyophilized Vials
  • World-class scientific expertise to develop and optimize lyophilization cycles.
  • Disposable (single-use system) manufacturing options.
  • Extensive range of vial sizes, including ISO standards.
  • 750 m2+ of global lyo capacity.
Prefilled Syringes and Cartridges
  • Aseptic Filling, Terminal Sterilization when required.
  • Broad range of sizes and configurations.
  • Disposable (single-use system manufacturing options).
  • Small and large batch sizes available.
  • Glass or polymeric options available.
Sterile Injectables Clinical Services
  • PFS plunger and backstop assembly
  • Needle safety device assembly
  • Auto-injector assembly
  • PFS and reference material binding
Biologic and Sensitive Molecules
  • Peristaltic pumps
  • Controlled-temperature mixing
  • Controlled-termperature filling
  • Cold chain storage and distribution
  • Assembly, packaging, and labeling at 2 C – 8 C
  • Filling under nitrogen

Sterile Injectable Device Assembly

Several options are available for your injectable device assembly needs, depending on your budget and your drug product.

Some injectable device assembly options include:

Additional services to help with any other injectable product needs:

Learn more about all our commercial packaging capabilities.

Sterile Dosage Forms

Commerical and Development

 Greenville, USAFerentino, ItalyMonza, ItalyGreenville, USAFerentino, ItalyMonza, Italy
Liquid Vials2 ml – 20 ml2 ml – 100 ml2 ml – 100 ml2 ml – 65 ml2 ml – 500 ml2 ml – 100 ml
Lyophilized Vials2 ml – 20 ml2 ml – 20 ml2 ml – 100 ml2 ml – 65 ml2 ml – 25 ml2 ml – 100 ml
PFS/Cartridges0.5 ml – 20 ml 0.5 ml – 20 ml0.5 ml – 20 ml  
  1. ISO and Non-ISO vials can be accommodated.
  2. Additional vial sizes available and can be shared by a Thermo Fisher representative.
  3. Development scale manufacturing capabilities suitable for clinical trial material manufacturing.
  4. Disposable (single-use system) manufacturing solutions available.
  5. Monza development capabilities will be available 2018.
  6. New capabilities are continually being added. A detailed list of current capabilities can be made available on request.

Learn more about our sites and their specific capabilities.

Download our Solid and Sterile Dose Form brochure.

Related Sites

Additional Resources