The Critical Role of Conversion Factor in Quantitative Determination of Host Cell DNA with ddPCR - Seguridad Mania.com - España y América Latina

This webinar will provide an in-depth exploration of a QbD-based method development approach for quantifying host cell DNA in gene therapy products, a critical quality attribute to ensure product safety and regulatory compliance. The session will begin by examining the measurement principles of two widely used techniques: qPCR and dPCR, while highlighting their respective advantages and limitations. A central focus will be on establishing a robust conversion factor for dPCR implementation. This factor is critical for accurately converting results from copies/μL, the standard dPCR output format, to ng/dose, as required by regulatory guidelines. The discussion will emphasize the importance of selecting an appropriate target gene and utilizing reliable reference materials to ensure precise reporting. Additionally, the webinar will address other essential aspects of method development, including sample dilution requirements, the primary sources of residual host cell DNA, and Further insights will cover additional aspects of method development, including sample dilution requirements, the primary sources of residual host cell DNA, and a summary of the method qualification results.