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The Gene Therapy stream focuses on the critical challenges facing the analysis, characterization, quality control and manufacture of gene therapies for clinical and commercial supply, viral and non-viral-based. Split across two back-to-back tracks, Gene Therapy CMC and Analytics, and Gene Therapy Manufacturing, topics include product and process characterization, CMC, upstream development, molecular biology, potency assays, comparability, emerging analytical technologies, impurities, quality control, comparability, process development, purification, formulation, scale-up and commercial manufacturing.

Conferences Include:

Gene Therapy CMC and Analytics
Gene Therapy Manufacturing

Keynote Presentations Include:

Technical Development and Comparability Strategies for Gene Therapies
Phillip RamseyPhillip Ramsey, Senior Vice President, Head, Technical Development, Sangamo Therapeutics

Evolution of Downstream Manufacturing Process Design for Productivity, Product Quality, and Process Consistency
Mi JinMi Jin, PhD, Head, Downstream and Drug Product Development, Spark Therapeutics Inc.
Cell Therapy

Featured Presentations Include:

Significance of Manufacturability Assessment during Novel AAV Capsid Early Discovery Process
Davide GianniDavide Gianni, PhD, Principal Scientist, Biogen

Continuous Downstream Purification of Viral Vectors
Caryn L. HeldtCaryn L. Heldt, PhD, Professor, Chemical Engineering, Michigan Technological University