Steriles

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

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.