Bioprocess monitoring and control are an essential requirement for safe and effective manufacture of bioproducts. This review provides an overview of some of the latest developments in analytical techniques, process variability, monitoring and control approaches for biologics, with a specific emphasis on the growing sector of cell and gene therapy. The monitoring and control challenges arising from the broad range of cell and gene therapy products, the complexity of these products and the processes required to produce them are outlined. Perspectives and implementation challenges are then set in the context of the regulatory framework.

中文翻译：

---

生物过程监测和控制：细胞和基因治疗的挑战

生物过程监测和控制是安全有效地生产生物产品的基本要求。本综述概述了生物制剂分析技术、过程可变性、监测和控制方法方面的一些最新发展，特别强调了细胞和基因治疗这一不断发展的领域。概述了广泛的细胞和基因治疗产品所带来的监测和控制挑战、这些产品的复杂性以及生产它们所需的过程。然后在监管框架的背景下设定前景和实施挑战。