Performance of Single-use Virus Filtration at Biopharmaceutical Manufacturing Scale

摘要

Commercial manufacturing of biologics such as monoclonal antibodies (mAbs) and recombinant proteins requires robust, reliable processes which cost-efficiently deliver high yields of a safe and effective product. In the past, when product titers of mAbs for example, were less than 0.5 g/L large stainless-steel bioreactors with volumes of 10,000 L were the norm for commercial production as these offered a high degree of standardization. The development of higher production titers (of up to 10 g/L or even higher) led to lower bioreactors volume and when in the late 1990s the first single-use (SU) bioreactors came to the market, these became an attractive alternative to stainless-steel for bioprocessing. Single-use has many benefits such as faster batch turn around. As soon as a batch is processed, a new pre-assembled and sterilized fluid flow path (this could be a SU bioreactor or a full end to end SU process) can be installed and ready to process, thus reducing shut-down time by eliminating (cleaning in place) CIP, sterilizing in place (SIP) and associated activities. The risk of product cross contamination is also reduced due to the fact that the SU parts which come in contact with the biological product come as pre-sterilized units.