More Sterile NDAs Than Any Other CDMO

Partner with Patheon, by Thermo Fisher Scientific, to access extensive sterile injectable product development capabilities for liquid-filled and lyophilized vials, including world-class expertise in lyophilization. With us, you’ll also have access to state-of-the-art development and commercial-scale GMP manufacturing for prefilled syringes and cartridges.

We offer you:

Flexible approaches to maximize speed and cost
Formulation and process development optimization for cost and quality
Broad range of vial sizes including ISO standard vials
Proven technology transfer experience
Scalability to commercial manufacturing
A strong regulatory track record

Need help with your next steriles project? Contact us. »

Sterile Development Services

With more than 20 years of experience in sterile injectables formulation and process development, including more than 240 biologic development programs, we know how to transform your discovery into a drug product designed to scale from preclinical development to commercial manufacture.

We provide:

A wide range of dose forms, including large and small-volume parenterals, liquid and lyophilized vials, pre-filled syringes, and cartridges
Formulation and process development
Lyophilization cycle development and optimization
Batch sizes to meet your clinical trial demands
Appropriate handling of sensitive and precious drug substance
Clinical trial services, including pre-filled syringe and auto-injector assembly
Aseptic filling and terminal sterilization

Let us help you transform your discovery into a drug product with the best possible chance for approval.

More Sterile NDAs Than Any Other CDMO

Sterile Development Services

Related Sites

Additional Resources