Preparing for success in gene therapy analytical development

In this expert roundtable, three experienced industry leaders in analytical development share dos and don’ts to set you up for future success in AAV gene therapy product characterization and QC. The panelists troubleshoot a variety of development tasks, including how to select a specific methodology for CQA measurement and potency assay development. Yan Zhi is a Director at CSL Behring, King of Prussia, PA, USA. Yan has over 15 years of leadership experience in biologics testing and cell and gene therapy development. She is currently responsible for the technical performance of Hemgenix to support worldwide markets at CSL Behring, following scientific and analytical leadership roles at Spirovant Sciences, Charles River Laboratories, FUJIFILM Diosynth, and WuXi AppTec. Jing Li is Associate Director of Analytical Tech Transfer, at AstraZeneca Rare Disease, Boston, MA, USA. Jing Li has extensive industry experience in analytical development, CMC, and structural mass spectrometry, contributing to biologics and gene therapy development at companies like Takeda, Bristol-Myers Squibb, and AbbVie. Andres Castillo is Global Market Development Manager at Thermo Fisher Scientific, Pacifica, CA, USA. Andres has over 6 years of experience in cell and gene therapy commercialization, specializing in cell therapy manufacturing, gene editing, and pharmaceutical analytical strategies.