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Upstream Process Development
CMC has considerable experience working with a variety of different host cell types, including CHO, NS0, HEK, hybridoma, E. coli, Pichia, and insect cells. Combined with our experience in alternative manufacturing platforms, including fed-batch, perfusion and concentrated fed-batch, we have a track record for delivering bioprocessing solutions to the upstream process development challenges of numerous clients.
At CMC, we will develop bioprocesses ‘from scratch’ for customers with no existing upstream process, or will re-design to optimize an existing process. Alternatively, we often support our customers with a fast and effective technology transfer to establish already proven upstream processes in our development laboratories, ensuring a seamless route to scale-up and cGMP manufacture.
CMC has experience with a multitude of different proteins. Whether your product is secreted, excreted, or intracellular, soluble or inclusion body, single peptide or multi-peptide, monomer or multimer, fragment or fusion protein, CMC can demonstrate relevant experience and an extensive platform for developing upstream processes.
Mammalian Upstream Development Services
The CMC Upstream manufacturing platform process is based upon chemically defined expansion and feed media. CMC has a strong working relationship will all of the major media vendors and can easily transfer in processes that are based upon other commercially available media.
Mammalian Platform equipment includes:
- Process development bioreactors: 5L & 15L
- Seed train: 20L & 40L bioreactors; 20/50 WAVE bioreactors
- 50L Hyclone SUB
- 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
Microbial Upstream Development Services
CMC's Microbial 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 Pichia process development
- Pilot-scale fermenters: 100L
- Dedicated microbial cGMP cell banking suite (class C)
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