Next-Generation Biotechnology Product Development, Manufacturing, and Control StrategiesPart 1: Upstream and Downstream Strategies

摘要

Future biomanufacturing must address industry drivers, including the need for decreasing cost of goods (CoG), increasing market globalization, shortening development time for pipeline products, reducing risk to patient supply, and improving product quality. A CASSS chemistry, manufacturing, and controls (CMC) forum entitled "Next-Generation Biotechnology Product Development, Manufacturing, and Control Strategies" took place on 16-17 July 2018 in Gaithersburg, MD, to address those opportunities.