Regulatory Perspectives on In-use Storage of Biologic Products: Phase Appropriate Microbial Challenge Studies

A review of the regulatory requirements and guidance recommendations to support storage conditions of reconstituted and/or diluted drug products during IND development and for BLA approval will be presented. Microbial challenge study design and data analysis will be discussed. Case studies will be presented to illustrate how the microbial challenge data support the label instructions for storage conditions.