Institute of Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe Institute of Technology, Fritz-Haber-Weg 2, 76131, Karlsruhe, Germany.
Anal Bioanal Chem. 2020 Apr;412(9):2047-2064. doi: 10.1007/s00216-020-02407-z. Epub 2020 Mar 7.
As competition in the biopharmaceutical market gets keener due to the market entry of biosimilars, process analytical technologies (PATs) play an important role for process automation and cost reduction. This article will give a general overview and address the recent innovations and applications of spectroscopic methods as PAT tools in the downstream processing of biologics. As data analysis strategies are a crucial part of PAT, the review discusses frequently used data analysis techniques and addresses data fusion methodologies as the combination of several sensors is moving forward in the field. The last chapter will give an outlook on the application of spectroscopic methods in combination with chemometrics and model predictive control (MPC) for downstream processes. Graphical abstract.
随着生物类似药的市场准入加剧了生物制药市场的竞争，过程分析技术（PAT）在工艺自动化和降低成本方面发挥着重要作用。本文将概述并介绍光谱方法作为生物制品下游处理中 PAT 工具的最新创新和应用。由于数据分析策略是 PAT 的重要组成部分，因此本文还讨论了常用的数据分析技术，并介绍了数据融合方法，因为在该领域中，多个传感器的组合正在向前推进。最后一章将展望光谱方法与化学计量学和模型预测控制（MPC）结合在下游工艺中的应用。
