CMC Biologics has considerable experience with a variety of host cell types, including CHO, NS0, HEK, PerC6, hybridoma, E. coli, Pichia, and various insect cells. The experience with a variety of host cell types, combined with our experience in alternative manufacturing platforms (including fed-batch, perfusion, and concentrated fed-batch), we have a solid track record of delivering bioprocessing solutions to numerous clients.
Our approach is flexible, based upon our clients’ needs. We can develop bioprocesses “from scratch” for customers with no existing upstream process, or we can redesign and optimize an existing process. In addition, our development laboratories often support our customers with fast and effective technology transfer to establish proven upstream processes, ensuring a seamless route to scale-up and cGMP manufacture.
We also have expertise with a wide variety of proteins. Whether your product is secreted or intracellular, soluble or inclusion body, single peptide or multi-peptide, monomer or multimer, fragment or fusion protein, CMC Biologics has relevant experience and an extensive platform for developing upstream processes.
Mammalian Upstream Development Services
Our upstream manufacturing platform process is based upon chemically defined expansion and feed media. We have a strong working relationship with all of the major media vendors. This allows us to easily transfer in processes that are based upon other commercially available hydrated or powdered media.
Mammalian platform equipment includes:
- Process development bioreactors: 5L & 15L glass bioreactors; 3L disposable bioreactors
- Seed train: 20L & 40L bioreactors; 20/50 WAVE bioreactors
- 50L hyclone or sartorius single-use bioreactors (SUBs)
- Concentrated fed-batch and perfusion technologies: ATF (alternating tangential flow), spin filter, and BioSep
- Mammalian-specific analytical support, e.g. Nova BioProfile Flex, Cedex, Protein A HPLC, glycan profiles
- Mammalian process platform
- Dedicated cell culture cGMP cell banking suites (class C)
Microbial Upstream Development Services
Our upstream development group has extensive experience in establishing, optimizing, and characterizing high cell density E. coli and Pichia fed-batch processes.
For E. coli, suitable expression vectors and host strains are available, and the microbial cGMP Cell Banking services are embedded in the development group. The overall focus is to develop high yielding cell lines and processes that are robust and scalable, with high productivity in regulatory friendly media.
Microbial platform equipment includes:
- Process development fermenters: 5L glass bioreactors with off-gas analysis
- Generic processes available for E. coli and Pichia
- Methanol feeding and oxygen enrichment available for process development
- Pilot-scale steel fermenters: 100L
- Dedicated microbial cGMP cell banking suite (class C)