IQ Physicochemical in-use WG

Sponsored by the Biologics CMC LG

Working Group Chair: Jing Liu, SeaGen

MISSION/OBJECTIVES:

• Share industry experience and provide recommendations.
• Gather cross-industry experience on current in-use stability study practices
• Publish a white paper to share industry experience
• Establish best practice, plan, perform and present in-use stability studies to support major markets