Integrating systems analysis and control for implementing process analytical technology in bioprocess development

Abstract This paper provides a perspective on the increasingly critical role that systems analysis and process control play in bioprocess development today. This is of particular importance to the manufacturers of biotech therapeutics since the product quality is critical and depends on the process and its control. Because a large number of process variables and raw materials can influence the overall outcome of a bioprocess, the correct determination of the process trajectory is often an intensive exercise. A follow‐up involving design of a suitable process control strategy for implementation of process conditions would be logical. However, such an exercise can no longer consider each unit operation one at a time but rather requires holistic inclusion of all upstream and downstream unit operations for successfully meeting the global standards laid down by various regulatory agencies by exploring the potential of process analytical technology ( PAT ) to achieve bigger objectives. In this perspective, the focus is on the core issues associated with process integration and how these may influence future process development. © 2014 Society of Chemical Industry