Manager, Labs PPD, part of Thermo Fisher Scientific Richmond, Virginia
The use of qPCR and dPCR has become useful for the study of many therapies, including but not limited to cell and gene therapies. However, there is almost no regulatory guidance towards these platforms, and therefore little harmonization on assay design, and parameters and criteria for method validation. This topic will focus on the differences between qPCR and dPCR, the benefits of both platforms, and when one technology might be a better fit for a study than the other. It will also cover the best practices for the design and execution a PCR method validation, using the recent discussion led by AAPS between 24 industry organizations.
Learning Objectives:
Upon completion, participants will be able to recommend the use of qPCR or dPCR within a study.
Upon completion, participants will be able to prepare for the needs of a PCR method development.
Upon completion, participants will be able to summarize the parameters and criteria needed for a PCR method validation.
