Biological Process Analytical Technology (BioPAT®)
Biopharmaceutical production is highly regulated to ensure patient safety and requires appropriate process control, process validation and product characterization. However, raw material variability, the biological production system as such and the robustness of individual process steps will influence product quality. Therefore, the industry and regulatory agencies have put in place a framework for process analytical technologies and quality by design to enable better process understanding and control to improve process robustness, product quality and hence patient safety.
