Over the years, we have successfully developed downstream processes for many types of biotherapeutics. Recombinant antibodies, for example, make up a large proportion of our customers’ needs. In this area, our “template” approach allows for speed and predictability as well as a smooth transition into manufacturing. We have 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 methodologies, uniquely position us to address the downstream challenges of a specific product.
At CMC Biologics, we can 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. This ensures a seamless route to scale-up and cGMP manufacture.
We have a track record of delivering bioprocessing solutions to address the downstream process development challenges of numerous clients. Our expertise with purification technologies and other processing technologies give us a decided edge in this area.
Our downstream platform includes the following:
- Standard Protein A-based process platforms
- Chromatography polishing steps; e.g., anion exchange, cation exchange, hydrophobic interaction, and hydroxyapatite
- Process development for complex proteins
- Development of viral inactivation and clearance steps
- Viral clearance strategies, protocols, and execution
- Impurity profiling and clearance
- Stability assessments for effective hold steps
- Process ranging and robustness studies to support process optimization and validation
- Development of solubilization and refolding processes for target proteins expressed as inclusion bodies
- Development of PEGylation and other conjugation processes
- Design of large-scale manufacturing equipment for conjugations
- Development of industrial-scale protein crystallization processes