Thermo Fisher Scientific

Richard Snyder, Ph.D., VP, Science and Technology, Pharma Services Group, Viral Vector Services

Waltham, MA
Several human clinical trials have been carried out using AAV and LV vectors for the treatment of various diseases. Many of these trials have demonstrated safety as well as therapeutic efficacy, and commercialized products have been licensed for sale. Viral gene transfer vector manufacturing for in vivo and ex vivo applications has largely been in support of early phase clinical trials, but as product candidates move to later development stages, demand is rapidly increasing for commercial grade vectors at a variety of scales. Decisions regarding vector design, manufacturing platform, product configuration, process control, and regulatory strategy have an impact on timelines and resources, raw materials sourcing, and analytical testing. To date, viral vector manufacturing and testing has utilized a diverse set of technologies and workflows. Establishing standardized workflows based on robust technologies will facilitate reproducible and streamlined manufacturing of products with consistent CQAs, broader access, and scalability. Developing standardized platforms that support an efficient path to the clinic and onto the marketplace while reducing risk helps to bring these cutting edge cell and gene therapies to patients in need.

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