Director BioAgilytix Labs, LLC. Durham, North Carolina
An evolution of drug modalities has occurred over the last several decades, including the emergence of cell and gene therapies. Gene therapy is a treatment modality that introduces genetic material into a patient for treatment of a disease. The transfer of genetic material or method of delivery is achieved via different delivery means; viral vectors are a commonly used mechanism. There are regulatory guidance recommendations on clinical safety assessments associated with vector shedding for gene therapies. In this presentation, several aspects of best practices around assay development and validation will be addressed including platform selections, method development considerations, as well as an understanding of regulatory requirements.
Learning Objectives:
Upon completion, participants will have an appreciation for the regulatory requirements associated with PCR shedding assay validation.
Upon completion, participants will understand the difference between qPCR and dPCR use for employing shedding assays.
Upon completion, participants will be exposed to case studies that demonstrate considerations for shedding assays.
