The Gene Therapy stream focuses on the critical challenges facing the analysis, characterization, quality control and manufacture of gene therapies, viral and non-viral based. Topics include product and process characterization, potency assays, comparability, emerging analytical technologies, impurities, quality control, comparability, process development, purification, formulation, scale-up and commercial manufacturing. 

Conferences Include:

Keynote and Featured Presentations

CMC Strategies for Process Intensification and Acceleration of IND Submission for Gene Therapies
Srinivas Chollangi, PhD, Director, Cell and Gene Therapy CMC, Sanofi


Phased Approach to Establishing Production Platforms
Terrence Dobrowsky, PhD, Head, Gene Therapy Drug Substance, Biogen


Production of AAV Vectors: Process Optimization towards Commercialization
Barbara Kraus, PhD, Head, Gene Therapy Process Development, Takeda


What Is in Those Capsids? AAV Capsid Content Is an Attribute with Many Measures
Herbert A. Runnels, PhD, Global CMC AAV Analytical Sponsor, Gene Therapy, Pfizer Inc.