Are You Really Ready To Transfer?

This segment of the Outsourced Pharma Live event, “Beyond Data Packages: De-Risking Tech Transfer To CDMOs,” outlines the internal readiness checks sponsors should complete before initiating a physical transfer, including whether critical process parameters are known and bounded, critical quality attributes are measurable and linked to process behavior, quality control methods are qualified and reproducible, and variability drivers are understood. Bikash also emphasizes why these readiness questions must be grounded in risk management, not paperwork exercises. Featuring Darren Dasburg, CEO, Clarus Biologics, and Bikash Chatterjee, President and CSO, Pharmatech Associates.