Development of cell and gene therapy (CGT) products provides many new challenges for the assurance of pathogen safety. With unique raw materials and testing schemes, CGT products can have substantially higher risk of virus contamination compared to traditional recombinant products, yet the viral clearance provided by their downstream purification steps can be significantly lower. One of the most effective and robust unit operations for removal of viral contaminants is virus filtration. Unfortunately, the very size-based mechanism which leads to its high degree of virus removal also makes virus filtration difficult to implement for many CGT manufacturing processes. In this presentation, I will discuss strategies to utilize the well-established performance of virus filters to increase pathogen safety for CGT products. Data illustrating effective viral clearance during gene therapy purification will be presented. In addition, the incorporation of filtration as an upstream barrier for protection of cell therapy products will be discussed. Overall, the increased risks associated with new therapeutic modalities call for implementation of robust protection strategies to ensure patient safety.

Role of virus filtration in achieving pathogen safety of gene and cell therapy products

2019 Spring National Meeting

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