Biologics manufacturing & Development Services
Comprehensive contract development. Reliable cGMP manufacturing. Gain a competitive advantage in both by choosing Patheon for your biopharmaceuticals and biosimilars. You’ll have access to end-to-end, fully integrated services for both drug substances and drug products, delivered on time and on budget. A simplified supply chain that accelerates development and keeps you ahead in the rapidly changing world of biologics.
With flexible capabilities across all bioprocessing stages, our expertise spans multiple mammalian cell lines, including CHO, myeloma, hybridoma and PER.C6 ®. We are continuously investing in our global network of facilities to ensure our clients have immediate access to leading-edge technologies, innovative solutions and unique financing opportunities.
With more than 20 years of process development experience, including more than 240 biologic development programs, we know how to transform your discovery into a drug substance via a sustainable process designed to scale from preclinical development to commercial manufacture. We’ll give you access to batch, fed-batch, perfusion and chromatography processes leveraging single-use and stainless steel systems.
More than 80% of our clients are emerging and midsize companies. We also work with the world’s 20 largest pharmaceutical companies. Our ability to meet the unique needs of clients of all types and sizes at every stage of the drug product life cycle has made Patheon a worldwide leader in pharmaceutical development services.
Companies put their trust in Patheon for our proven expertise in bringing drug candidates from preclinical development through production. Patheon clients have earned twice as many NDA approvals as those of any other CDMO.* With us you’ll have direct access to the full range of high-quality sterile dosage forms, with exceptional expertise in lyophilization and ready-to-use products. More than 20 years of experience including more than 100 protein projects. And the ability to launch products anywhere in the world.
*Source: PharmSource ® Trend Report, March, 2016.
Commercial Product Supply
Unfailing quality. This is why clients the world over entrust Patheon with their commercial product supply. Since 2006, our facilities have undergone more than 2,300 customer audits and more than 325 regulatory inspections. What's more, the U.S. FDA has issued us 33 pre-approval inspection waivers between 2006 and 2016.
Your product will be in the capable hands of an experienced project manager and cross-functional team at world-class facilities in Europe, North America and Australia. You’ll have access to the full scope of cGMP manufacturing capabilities, including: state-of-the-art processes and innovative USP/DSP technologies. Comprehensive analytical services. Full regulatory support, including preparation of CMC documentation. Award-winning tech transfer expertise. Right First Time/On-Time delivery in the required quantity. Innovative strategies for late life cycle and biosimilar products.