CQAs are essential attributes that must be monitored and controlled to ensure product quality. Understanding and defining CQAs has been challenging in the relatively new field of gene therapy, but is crucial to ensure patient safety and to meet regulatory standards. We’ll explore phase-appropriate development of process controls and discuss strategies that can help accelerate commercialization of AAV gene therapies.

Session Chairs: Christiane Niederlaender, Parexel International, Leslie Nash, Health Canada, and Andrea Challand F. Hoffman La Roche Ltd

Session Speakers:

Release Quality Attributes of rAAV-Based Gene Therapy Medicinal Products

Laura Rodríguez, Spanish Agency of Medicines and Medical Products (AEMPS)

AAV Critical Quality Attributes: Comprehensive Analytical Control Strategies from Release to Characterization

Thomas Powers, Pfizer, Inc.

Control Strategies using CQAs for Method Changes and Comparability for Gene Therapies

Phillip Ramsey, Sangamo Therapeutics, Inc.

CQAs and Strategies to Accelerate the Development of Gene Therapies

Catherine Campbell, 4D Molecular Therapeutics

Additional Panelists:

Tania Rosen-Cheriyan, CBER, FDA

Francis Galaway, Medicines and Healthcare products Regulatory Agency (MHRA)

Andrea Challand

Appearances