The cell culture impact factors affecting critical quality attributes

Identifying the key factors influencing critical quality attributes of drug product is essential for the success of drug development programs. Advancement of enabling analytical tools allows better understanding of how the cell culture process conditions can significantly affect product quality attributes. In-depth evaluation of cell culture’s influence on therapeutic protein quality could lead to development of effective means to monitor and control the process to ensure consistent delivery of high quality product. Here we present an application of systems biology approach to identify genetic and metabolic markers associated with product quality attributes for development of predictive tools and control levers. Mechanistic insight into the integration of intrinsic (genetic) and external (process) factors influencing critical quality attributes will also be discussed.