Session Chairs: JR Dobbins, Eli Lilly and Company, Bryan Silvey, GxP/CMC Principle in Cell Therapy, and Seshu Tyagarajan, Candel Therapeutics

Viral vectors (VV) are emerging as a transformative gene therapies modality for treating a variety of genetic disorders. A multitude of VV containing products have progressed into clinical development, and a subset have become commercial products.   As a result of this progression, substantial advances have been made in the chemistry, manufacturing, and control (CMC) of VV.

This session will provide insight into advances in CMC with a focus on novel VV modalities, leveraging platforms to accelerate and streamline development, phase appropriate innovative analytical testing and characterization approaches, and associated regulatory considerations. Attendees will have the opportunity to hear from industry and Health authority experts through presentations focused on case studies, practical application examples and participate in an interactive panel discussion. Attending this session will provide insight into the current industry and regulatory advances and trends with the use of VV in gene therapies. 

Session Speakers:

Advanced Sequencing Approaches for Comprehensive AAV Vector Characterization

Will Arnold, ElevateBio

Cell Line Engineering for in Vitro AAV Potency Assays

Hsiang Chen Chou, Biogen

Integrating Process and Analytics: A Prerequisite to Streamlining the Production of Viral Vectors

Amitabha Deb, CellGene Consulting LLC

Hsiang Chen Chou

Appearances