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The development and implementation of analytical tools and platforms has taken center stage as the AAV-driven gene therapy industry continues to advance and mature. Generating a compelling data package is of growing importance in securing the future of biotech companies in the sector. Success in this increasingly competitive race will largely depend on who can most efficiently and cost-effectively develop a robust AAV production process that is fit for commercial purpose.
In this webinar, a panel of AAV analytical development experts will deliver strategic and technical insights along with practical advice on how to prepare early to meet a continually evolving set of CMC challenges, and avoid the sort of delays later in development that can prove fatal to gene therapy companies in the current funding environment.
Join thought leaders in analytical development from Alexion - AstraZeneca Rare Disease, Thermo Fisher Scientific, CSL Behring, and more as they reveal how to:
- Leverage critical analytical methods required for comprehensive AAV characterization and regulatory compliance.
- Enable accurate critical quality attribute (CQA) measurements, including quantitation of titer, at scale utilizing either qPCR or dPCR systems
- Employ strategies to ensure consistency and reproducibility in analytical testing across different batches and production scales
Yan Zhi
Director, Cell and Gene Therapy Product Owner, Process Engineering at CSL Behring
After postdoctoral research training with Dr. James M. Wilson at the Institute of Human Gene Therapy, University of Pennsylvania, Yan spent over 15 years in global contract testing organizations (WuXi AppTec and Charles River Laboratories) to provide scientific leadership to Biologics testing services with the strong focus on cell and gene therapy industry as well as a global contract development and manufacturing organization (Fujifilm Diosynth Biotechnologies) to design cell and gene therapy product development programs from clinical to commercial manufacturing. In 2020, Yan joined Spirovant Sciences, Inc. to lead the analytical development and develop CMC strategy of a novel serotype AAV-based in vivo gene therapy product for IND submission. Since 2022, Yan has been a core team member for technical transfer and the CMC lead working with regulatory, quality, and supply teams at CSL Behring to ensure the commercial supply of Hemgenix as well as regulatory submissions to additional countries. Yan received a PhD in Microbiology and Molecular Genetics from the University of California, Irvine, and a BA in Molecular Biology from the University of Science & Technology of China. She is a leading author and co-author of numerous publications in peer-reviewed scientific journals and a patent holder.
Jing Li
Associate Director of Analytical Tech Transfer, Genomic Medicine Unit at Alexion
Dr. Jing Li is Associate Director of Analytical Tech Transfer at the Genomic Medicine Unit within Alexion, AstraZeneca Rare Disease unit. Dr. Li obtained her BS at the University of Science and Technology of China, and her PhD at Washington University in St. Louis, where she utilized biophysics and structural mass spectrometry technologies to study biotherapeutic proteins and interactions. She has extensive industry experience in analytical development, CMC, and structural mass spectrometry and worked at Takeda, Bristol Myers Squibb, AbbVie, and Ring Therapeutics with increasing responsibilities. She has made important contributions to the discovery, preclinical study, and development of biologics drug products and gene therapy modalities.
Andres Castillo
Global Market Development Manager at Thermo Fisher Scientifc
Andres Castillo is a Global Market Development Manager at Thermo Fisher Scientific. He holds a BS and an MBA from the University of Washington.
With over six years of experience in commercializing cell and gene therapies, Andres has worked as a research scientist in both GMP and non-GMP settings, specializing in cell therapy manufacturing and gene editing applications. In his current role, he focuses on the global commercial strategy and rollout of pharmaceutical analytics technology in cell and gene therapies.
