Streamlining data management & process analytics for the manufacturing of cell & gene therapies
With a likely increase in production volumes of cell and gene therapies, and the more widespread implementation of Quality by Design principles, the amount of process data to manage (i.e. collect, validate, analyze and interpret) will increase significantly. Data guides the manufacturing operations, it allows monitoring and control of the process, and it assures product quality and regulatory compliance. More recently big data, artificial intelligence and machine learning techniques promise a surge in data-driven insights, affecting nearly all aspects of R&D and manufacturing of cell and gene therapies. However, without proper tools and solid data foundations, data management will constitute a bottleneck in the production of these novel therapies. The aim of this article is to discuss steps needed in order to address the data management challenge.