Building Characterization Assays to Support Early-Stage saRNA Development and QC Alignment

This webinar will discuss considerations for building characterization assays to support early-stage saRNA development and alignment across CMC and quality functions. Emphasis will be placed on establishing fit-for-purpose assays to help define product quality and inform key development decisions.

Using potency as a case study, the session will outline the approach to method development, including efforts to establish stability-indicating capability. Key observations from method refinement will be highlighted, along with challenges encountered in ensuring robustness and interpretability of results across development stages.
Overall, the session aims to provide practical perspectives on developing and evolving assay strategies in support of early-stage programs, including considerations for analytical consistency, data integrity, and alignment with regulatory expectations.

Presented by Yun-Ting Kao, Senior Scientist at Immunomic Therapeutics

Yun-Ting Kao is a Senior Scientist at Immunomic Therapeutics, where she leads analytical development for RNA-based immunotherapies. She specializes in developing and optimizing characterization and potency assays to support R&D, CMC activities, and regulatory submissions.
She leads analytical strategies for mRNA drug substance and drug product, including stability, release testing, and method qualification. She partners closely with CROs and CDMOs to ensure data quality and consistency and is particularly focused on solving complex analytical challenges. Her work supports the development of robust, phase-appropriate solutions that advance programs toward clinical readiness.
Beyond her technical work, she is passionate about science communication and building connections across the biotechnology community. She actively supports mentorship, knowledge sharing, and professional engagement, fostering inclusive environments and meaningful collaboration across the field.

Followed by a live question and answers session