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Mid- to Large-Scale Plant (Visp, Switzerland)
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The new state of the art facility allows for cGMP manufacture of parenteral grade microbially derived biopharmaceuticals. Intracellularly accumulated products as well as secreted products can be equally processed in the new production line which delivers bulk drug substance. cGMP conformity including clean room classification was cross-checked during the design phase with Swiss regulatory authorities. The layout of the highly automated multi-product line is based on a high performance 1000 litre bioreactor suitable for high cell density fermentation. Besides standard chromatographic and ultrafiltration unit operations, the ex-proof design in upstream as well as downstream areas allows for solvent feeds in fermentation and for implementation of HPLC purification steps in protein and peptide purification.
The facility offers the perfect environment for process development, scale-up, and supply of clinical and commercial quantities of microbially-derived material produced to cGMP regulations.
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