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:
- Large volume parenterals
- Small volume parenterals
- Liquid filled vials
- Lyophilized vials
- Pre-filled syringes
- Pre-filled cartridges
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.
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| 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.
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| 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.
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| Sterile Injectables Clinical Services |
- PFS plunger and backstop assembly
- Needle safety device assembly
- Auto-injector assembly
- PFS and reference material binding
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| 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
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Sterile Dosage Forms
Commerical and Development
| |
Greenville, USA |
Ferentino, Italy |
Monza, Italy |
Greenville, USA |
Ferentino, Italy |
Monza, Italy |
| |
Development
|
Commerical
|
| Liquid Vials |
2 ml – 20 ml |
2 ml – 100 ml |
2 ml – 100 ml |
2 ml – 65 ml |
2 ml – 500 ml |
2 ml – 100 ml |
| Lyophilized Vials |
2 ml – 20 ml |
2 ml – 20 ml |
2 ml – 100 ml |
2 ml – 65 ml |
2 ml – 25 ml |
2 ml – 100 ml |
| PFS/Cartridges |
0.5 ml – 20 ml |
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0.5 ml – 20 ml |
0.5 ml – 20 ml |
|
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- ISO and Non-ISO vials can be accomodated.
- Additional vial sizes available and can be shared by a Thermo Fisher representative.
- Development scale manufacturing capabilities suitable for clinical trial material manufacturing.
- Disposable (single-use system) manufacturing solutions available.
- Monza development capabilities will be available 2018.
- New capabilities are continually being added. A detailed list of current capabilities can be made available on request.
