The Critical Role of Conversion Factor in Quantitative Determination of Host Cell DNA with dPCR

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 a summary of the method qualification results.

Presented by Haiqing Yu, Senior Scientist, Analytical Development Department at Sanofi.

Haiqing Yu is a Senior Scientist in the Analytical Development Department at Sanofi. She earned a Ph.D. in Biochemical Engineering, specializing in large molecule chemistry and separation. Following her doctoral studies, she conducted academic research in the physical chemistry, characterization, and analytical method development for large molecules before transitioning to the biopharmaceutical industry in 2016. At Sanofi, Haiqing has focused on developing analytical methods for impurities, product characterization, and potency, employing a wide range of techniques including immunoassays, PCR, HPLC, and flow cytometry. Her work has supported diverse modalities such as recombinant proteins, monoclonal antibodies, AAV, LNP-mRNA, and CAR-T therapies in a GMP environment. Haiqing has contributed to both early- and late-stage projects, spanning clinical and commercial product development. She is passionate about applying scientific insights in analytics to drive innovation and ensure robust, reliable progress in the field.