Ensuring virus safety is of utmost importance in the Biopharmaceutical industry. Mammalian cell culture process present a unique challenge as these processes are inherently prone to microbial and viral contaminations. The cell culture bioreactor is a perfect environment for the proliferation of these contaminants and the introduction of a very low level contamination can quickly replicate into a major contamination. Past experience has shown that raw materials may be a high risk for introducing viral and bacterial contaminants. Bacterial contaminants can be easily removed by 0.1 or 0.2 μm sterilizing grade membranes, however small viruses (such as Vesivius, MVM) are not removed by these filters. In addition, testing raw materials may not be adequate since low levels of virus contamination may go undetected, hence a mitigation strategy to treat all raw materials which enter the bioreactor for virus removal/inactivation is becoming more popular in the industry. Adventitious contamination events have occurred in the past and may have severe consequences, such as GMP facility contamination, facility shutdown leading to drug shortages, financial losses and lost market share.<br/> <br/>Current risk mitigation technologies such as HTST, UV-C, and gamma irradiation are useful, however not always easy to implement and are not cost effective. Size exclusion based filtration is the preferred technology for viral clearance, as it is robust and non-invasive. Current downstream virus retentive membranes do not possess the flux rate or economics when it comes to filtration of cell culture media. Therefore a novel membrane has been developed by Sartorius Stedim to mitigate contamination risks in the bioreactor from chemically defined media and raw materials. The purpose of this study was to determine the capacity of Virosart® Media for chemically defined media as well as to investigate the effect of filtration on subsequent cell growth performance.<br/>

Case study: Virus risk mitigation in cell culture media lab-scale to pilot-scale – virus retentive filtration and cell growth studies

255th National Meeting (2018)

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