The Data Package Blind Spots That Create Surprises

This segment of the Outsourced Pharma Live event, “Beyond Data Packages: De-Risking Tech Transfer To CDMOs,” examines where sponsor data packages most often fall short, including assumptions that equipment, raw materials, water systems, hold times, sampling methods, and undocumented process adjustments will transfer cleanly. Darren and Bikash also explain why sponsors should align with CDMOs early on raw data access, quality system expectations, deviations, and the characterization data needed to support future comparability arguments. Featuring Darren Dasburg, CEO, Clarus Biologics, and Bikash Chatterjee, President and CSO, Pharmatech Associates.