Risk-reduction and Economic Considerations for Implementing Upstream Virus Filtration
Vaccines, viral vectors, and cell based therapies present special challenges for virus safety. Viral clearance approaches traditionally used in biopharmaceutical products, such as size exclusion or chemical inactivation, are often not useful when the product itself is a virus or a living cell. Considering lessons learned from the past, regulatory bodies and industry have striven to understand the risk associated with manufacturing of vaccines and novel therapies, and to implement barriers to potential viral contaminants. This presentation will examine application of virus safety principles to virus- and cell-based products. Selection of virus-free raw materials, safety testing of cell and virus stocks, and sensitive tests for detection of contaminating viruses during the manufacturing process are critical elements of a viral safety plan. Viral clearance steps may also be useful in some circumstances, such as the removal of helper viruses from viral vectors. These approaches can be combined to create comprehensive viral safety strategies that minimize the risk of viral contamination.
Michael Cunningham, Ph.D. -
Associate Director, Applications, MSAT,