Comprehensive Development and Clinical Manufacturing Services for Biologics
From Drug Substance
Your molecule has the power to change lives and shape the future. Let our biologics experts show you how to speed development and unleash the potential of your discovery. Patheon, by Thermo Fisher Scientific, offers you the flexibility and speed to help you get there ahead of schedule while maintaining the highest quality.
We bring deep scientific expertise to every challenge and our proven track record of scaling up biologics help ensure you gain cost and time savings at every stage of the biologic development process.
Our experts understand the long and complex journey ahead, and are as committed to your success as you are. We are driven by science and have the experience to solve complex large molecule challenges.
We pride ourselves on our ability to create flexible options for our clients. We think strategically to offer development solutions that meet the unique needs of your molecule. We can work with your cell lines, media, and processes. Our contracts are individualized to meet your requirements, we do not require you to use proprietary technology, and we do not charge royalties. Our strong reputation is built on successfully transferring complex molecules. You’ll have access to end-to-end, fully integrated services for both drug substances and drug products, delivered on time and on budget—and a simplified supply chain that accelerates development and keeps you ahead in the rapidly changing world of large molecule biologics.
Quick to Clinic™ Program for First-in-Human Biologic Clinical Trials
The pressure to file an IND makes accelerated Phase I safety testing a priority. With the Quick to Clinic™ program, we can deliver your large molecule drug product for first-in-human studies in as little as 14 months. Now you can meet important milestones—such as filing the IND or securing additional funding—with all the confidence your project needs, and we can supply. To help reduce the time it takes to get your discovery to patients who need it, our Quick to Clinic™ for Biologics is made with speed and flexibility.
Process Development Experience and Expertise
We apply our deep process development skills to significantly increase the batch yield and reduce processing time for your molecule. Applying Design of Experiment (DoE) methodology to both upstream and downstream development, we define the CPPs and CQAs that enable robust processes, maximize yields, and optimize throughput.
For upstream process development, we utilize the Sartorius ambr® 15 and 250 systems as well as 10 L single-use bioreactors to define optimal feed and processing conditions. For downstream process development, we employ the use of high throughput resin screening and Freedom EVO® platform with Repligen RoboColumn® system during development and optimization with on column confirmatory runs up to 5 cm inner diameter columns at bench scale.
We bring more than 20 years of process development experience, including more than 240 biologic development programs, and 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 fed-batch, perfusion and XD® processes technologies and purification processes leveraging single-use, disposable technologies.
- Full process development capabilities for mammalian recombinant proteins including monoclonal antibodies
- Significant experience with CHO (Chinese hamster ovary) and other commercial cell lines
- Bioprocessing capability at scales up to 2,000 L, across multiple single-use platforms
- Fed batch and perfusion cell culture processes
- Time and cost-saving technologies, including XD™ high density cell culture
- Proven, reliable cGMP biologics manufacturing
- Cost modeling to develop biomanufacturing strategies
- Fast, flexible, complete solutions for FIH trials
- Process development optimization for cost and quality
- Flexible approaches to maximize speed and cost
- Proven technology transfer experience
- Scalability to commercial manufacturing
- Strong regulatory track record
With a fully integrated global network of cGMP facilities across Europe, North America, and Australia, we offer you the flexibility to adapt to market changes and shifts in your product development strategy. After process development, our award winning Tech Transfer team will move your project to one of our cGMP operations for scale-up and production of your development and commercial materials. We are leaders in manufacturing monoclonal antibodies and other mammalian recombinant proteins using single-use technologies. Our expertise spans multiple commercial cell lines including CHO. We also specialize in fed-batch and perfusion cell culture processing up to 2,000 L.
Our analytical capabilities include rapid identification and characterization of your recombinant protein or antibody, development and implementation of cGMP methodologies and data generation for regulatory submissions. Both development and manufacturing analytical methods are created by the same team to avoid delays and errors created by hand-offs. Our breadth of analytical services and capabilities include: glycan profiling, ELISA assays for product and impurity assessments, gel and capillary based electrophoresis, gel and capillary based isoelectric focusing, residual DNA detection, cell-based bioassays, immunologic and colorimetric assays, chromatography, and mass spectrometry. Work with one partner for both drug substance and drug product manufacturing at the development and commercial scale. Our knowledge of formulation development and bio- processing ensures that your molecule is “formulation ready” regardless of the stage you are at.
Tech Transfer Expertise
Technology transfers, either for a scale-up or a move to another facility, are part of the normal course of business. Even when the transfer is urgent, our team has a proven track record of quick, effective executions to get your project back on track and preserve product supply. In 2017 alone, we completed 185 technology transfers: 44 drug substance, three development and 138 commercial.
In all cases, we are driven by your deadlines, flexible in our approach and determined to get it Right-The-First-Time, every time. In late clinical phases, and as part of the establishment of your commercial supply, Thermo Fisher Scientific provides a complete validation package according to regulatory and cGMP guidelines, which includes:
- BLA/PPQ enabling process characterization and validation activities
- Validation of analytical methods
- ICH stability studies
- Container shipment studies
- CMC documentation in CTD format
We offer a depth and breadth of innovative biologic capabilities from development to commercialization, employing pioneering new technologies to improve the manufacturing process—focusing precisely on every step, but never forgetting the end goal. We think strategically to offer flexible, fast, efficient approaches to helping your discovery through the complex journey to market. These are the scientists, engineers and professionals of Thermo Fisher Scientific, who apply a science-driven, risk-based approach to every step of the biologic development and manufacturing process. They draw on years of experience, and partner with you at the stage of development that’s most advantageous for your business. Because they believe this is the best way to make certain your discovery lives up to its promise to the patients who need it most.
With an integrated network of sites offering a range of upstream and downstream capabilities, we will assign your program to experienced project managers and cross functional technical teams with the skills and experience needed to keep you on the path to success. 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.