结晶是古老的分离与提纯单元操作之一，如今已发展成为生产具有特定性质的高附加值产品以及建立高效制造过程的技术。本文中，我们综述了制药工业中晶体工程以及结晶过程设计和控制的最新研究进展，系统地总结了理解和开发新型晶体如共晶、多晶型、溶剂化物的方法，包括一些重要的进展，如第一个共晶药物Entresto (诺华) 的诞生以及Orkambi (福泰) 连续制造过程获批。与不同的过程控制策略和新型的结晶器相结合，传统的釜式和日渐成熟的连续结晶过程正不断地满足制药工业的需求。结晶过程的设计和控制已使几种创新型结晶器的设计实现连续操作且性能良好。本文还综述了过程分析技术最新的重要研究进展。

Crystallization is one of the oldest separation and purification unit operations, and has recently contributed to significant improvements in producing higher-value products with specific properties and in building efficient manufacturing processes. In this paper, we review recent developments in crystal engineering and crystallization process design and control in the pharmaceutical industry. We systematically summarize recent methods for understanding and developing new types of crystals such as co-crystals, polymorphs, and solvates, and include several milestones such as the launch of the first co-crystal drug, Entresto (Novartis), and the continuous manufacture of Orkambi (Vertex). Conventional batch and continuous processes, which are becoming increasingly mature, are being coupled with various control strategies and the recently developed crystallizers are thus adapting to the needs of the pharmaceutical industry. The development of crystallization process design and control has led to the appearance of several new and innovative crystallizer geometries for continuous operation and improved performance. This paper also reviews major recent progress in the area of process analytical technology.