Considerations for Biodistribution and Viral Shedding Assays in Regulated Bioanalysis

Cell and gene therapies (CGT) are rapidly emerging and evolving as promising therapies for a variety of disease indications. It is important to understand the distribution, persistence and clearance of these products in vivo from the site of administration to target and non-target tissues and biofluids by conducting biodistribution studies. In addition, with the use of viral vectors, it is important to understand the release of virus-based therapy products from patients by evaluating viral shedding in different matrices. Biodistribution and shedding assays are commonly conducted via qPCR, however, there is limited information and guidance on how to develop these assays in regulated bioanalysis. In this webinar, we will discuss the challenges and considerations for developing and validating biodistribution and vector shedding assays in regulated studies.