Continuous processing has been garnering much interest lately for production of biopharmaceutical products. Purported benefits include higher productivity (10-15X), significant shrinkage in facility footprint as well as equipment cost, and improved process control and consistency in product quality. However, industrial implementation remains a non-trivial task due to the significant complexities associated with controlling continuous processes. Real time monitoring of critical quality attributes followed by real time process control while desired, may not be feasible for every attribute and for every unit operation. This article presents a perspective on the challenges that are faced while developing and implementing a robust and adaptable automated control system for continuous biopharmaceutical processes. Potential solutions are presented together with gaps that have been identified.

连续加工近来已引起人们对生物制药产品生产的极大兴趣。声称的好处包括更高的生产率（10-15倍），设施占地面积和设备成本的显着减少以及改进的过程控制和产品质量的一致性。然而，由于与控制连续过程有关的显着复杂性，工业实施仍然是一项艰巨的任务。对关键质量属性进行实时监视，然后在需要时进行实时过程控制，可能对每个属性和每个单元操作都不可行。本文介绍了针对连续生物制药过程开发和实施强大且适应性强的自动化控制系统时面临的挑战。