At the end of 2019, there were 1000+ advanced therapy medical products (ATMP) tested in clinical 1-3 phase trials. Virus safety of ATMPs is one of the most expensive and challenging steps in bioprocessing. Because the cell therapies cannot be sterilized, all components, including basal media and supplements, that come in contact with the cells must be virus-free. Nanofiltration is an established, robust and reliable method of physically removing viruses from protein solutions, including cell culture media components. However, designing a cost-efficient nanofiltration process is resource demanding, and the high price of single-use virus-removal filters is hindering their wide-spread application in cell therapies. There is need for cost-efficient high performance virus removal filters for bioprocessing cell therapies and biologics.
A Swedish company has developed a novel nanocellulose-based filter paper capable of removing even the smallest and most resistant to disinfection viruses from protein solutions in principle as easily as brewing coffee. The nanocelllulose-based virus removal filter paper combines excellent performance (in terms of virus clearance, flow properties, and protein throughput) with unparalleled cost-efficiency, which can dramatically improve the biosafety of cell therapies with little additional cost. The platform has been validated through numerous external validations with top-global biopharmaceutical industry.
The technology is useful in all steps of bioprocessing, where virus safety is desired or stipulated for regulatory approval, including both upstream and downstream processing. Nanofiltration for ATMPs is an emerging field of application for virus removal filters considering the large number of ATMPs currently tested in clinical trials.