Biologics manufacturing & Development Services
Comprehensive contract development. Reliable cGMP manufacturing. Gain a competitive advantage in both by choosing Patheon, a part of Thermo Fisher Scientific, 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 large molecule biologics.
With flexible capabilities across all bioprocessing stages, our expertise spans multiple mammalian cell lines, including CHO, myeloma, hybridoma, and more. 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.
Download our Biologics Overview Brochure see see our full biologics capabilities.
Biologics Technical Capabilities
Our breadth and depth of capabilities are designed to ensure the highest quality development and manufacturing of even the most complex recombinant proteins and monoclonal antibodies. These capabilities include:
- Full Process Development Capabilities for mAb (Monoclonal antibodies) and non-mAb products
- Bioprocessing capability at scales up to 2000L, across multiple single-use technologies
- Proven, reliable cGMP biologics manufacturing
- Time and cost-saving technologies, including XD™ high density cell culture
- CHO, myeloma and hybridoma commercial cell lines
- Fed batch, perfusion and chromatography processes
- Reliable, routine commercial drug substance supply
With an integrated network of sites offering a range of upstream and downstream capabilities, we can ensure your project is assigned to experienced project managers and cross functional technical teams with the skills and experience needed to keep your project on the path to success. And when your program is ready for commercialization, our global network gives you access to end-to-end specialized drug substance and drug product technologies through a single CDMO.
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 us a worldwide leader in pharmaceutical development services.
Companies put their trust in us for our proven expertise in bringing drug candidates from preclinical development through production. Our 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 us 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.