The fermentation & upstream process platform ensures the following activities:
- development and optimization of fermentation conditions using a DoE approach,
- production of biologics in 50L bioreactor/fermenter using either our standard high cell density fed-batch protocol (for R&D use) or the developed and optimized methods (for applications requiring GLP grade),
- harvest of the supernatant (P. pastoris) or the cell paste (E. coli),
- protein and plasmid extractions using soft lysis protocols ensuring high recovery yield without any damage on the biologics structure,
- clarification and sterile filtration of supernatants and cell extracts,
- transfer and scaling-up studies based on chemical engineering.
A park of four identical stainless steel fermenters (Biostat® C+) is used for the fast fermentation development and optimization as well as for R&D and GLP production batches.
Fermentation conditions are scalable and directly transferable to high scale industrial fermenters without any further development.