Our Microbial Cell Line 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.
E. coli cell line development
- In-house developed expression vectors
- Host strains HMS174 and BL21 available
- 2 x 450 and 2 x 1500L stainless steel GMP manufacturing
- All volumes are working volumes
- Batch and fed-batch operation
- Methanol feed (designed [or can be used for] for Pichia fermentations)
- Four separate purification suites equipped with state-of-the-art purification equipment, including: continuous centrifugation, UF/DF, homogenization, equipment for refolding, and a wide range of chromatographic columns and systems
- Bulk lyophilization
- Class A environment for aseptic filling of drug substance
- Analysis and QP release of drug substance and drug product