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Ultragenyx Gene Therapy is focused on advancing AAV-based gene therapies for rare, but serious, genetic diseases. Potency assessment for such advanced therapeutic product is of critical importance, but can also be very challenging…
The development of a relative potency assay to support biologic drug products requires significant budget, resources, and time to achieve the desired quality for release testing…
With increasing numbers of cell and gene therapy products in development and entering commercialization, more and more sponsors are facing a unique set of challenges of developing bioassays for cell and gene therapy products…