This bachelor thesis has been created to cover the development of a bioprocess, which was
generated in the FH-Bachelor degree course “Bioengineering” at the FH Campus Wien in a project work named bioprocess engineering. The intention is to develop a process for producing a recombinant protein for pharmaceutical purposes. For this process of essential importance, at all levels of technical planning and documentation, is the compliance with the high demands on a good and feasible manufacturing and documentation practice for the biopharmaceutical industry. The process is separated into the following steps: upstream, downstream, filling, cleaning and sterilization. In this document the unit operation “batch process” is accurately described. The batch cultivation occurs in exactly defined conditions, with a simple control system, regulation of the process and a low risk of contamination. These are all used to generate the cells through batch fermentation on a laboratory scale to gain a sufficient amount of biomass for the production reactor.