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Downstream Process Development
CMC has successfully developed downstream processes for many types of biotherapeutics. Recombinant antibodies, for example, make up a large proportion of our customers’ needs. Process development for these products benefits from a ‘template’ approach that allows for both speed and predictability as well as a smooth transition into manufacturing. CMC has also developed processes for a substantial number of more complex, recombinant proteins. Our experienced personnel, plus our focus on integration of analytical and protein/process characterization methodolgies into the process development program, places CMC in a unique position to address the downstream challenges for your specific product.
At CMC, we will develop bioprocesses ‘from inception’, or optimize an existing process. Alternatively, we often support our customers with a fast and effective technology transfer, to establish already proven downstream processes in our development laboratories, ensuring a seamless route to scale-up and cGMP manufacture.
With our experience on all the familiar and industry-wide applied purification technologies, and with some processing technologies that are less conventional but highly effective in an industrial setting, we have a track record for delivering bioprocessing solutions to the downstream process development challenges of numerous clients.
Our downstream platform includes the following:
Antibody Processing
- Standard Protein A-based process platforms
- Chromatography polishing steps, e.g. anion exchange, cation exchange, hydrophobic interaction and hydroxyapatite
Non-antibody Proteins
- Process development for complex proteins
Viral Clearance
- Development of viral inactivation and clearance steps
- Viral clearance strategies, protocols and execution
Process Characterization
- Impurity profiling and clearance
- Stability assessments for effective hold steps
- Process ranging and robustness studies to support process optimization and validation
Protein Refolding
- Development of solubilization and refolding processes for target proteins expressed as inclusion bodies
Conjugation
- Development of PEGylation and other conjugation processes
- Design of large scale manufacturing equipment for conjugations
Industrial Crystallization
- Development of industrial scale protein crystallization processes
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