PROCESS DEVELOPMENT FOR PRODUCTION OF ACTIVE PHARMACEUTICAL INGREDIENTS WITH PICHIA PASTORIS

Integrated Bioprocesses as a direct technological link between methods for the cultivation of the yeast Pichia pastoris and additional down-stream procedures ranging from cross-flow filtration for product recovery up to purification with combined chromatography systems are developed for a fully automated production of recombinant pharmaceutical proteins. The set-up of an appropriate 40 l pilot plant with an extended Process Analytical Technology (PAT) for on-line monitoring of important process variables, e.g. the recombinant product, as well as the development of complex control strategies by means of Apparent Processing with a real-time simulation system are explained.