Abstract

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

中文翻译：

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对生物制药下游加工中光学光谱作为 PAT 的最新趋势的批判性回顾和未来前景

 抽象的

随着生物仿制药的进入，生物制药市场的竞争变得更加激烈，过程分析技术（PAT）在过程自动化和降低成本方面发挥着重要作用。本文将概述并讨论光谱方法作为 PAT 工具在生物制品下游加工中的最新创新和应用。由于数据分析策略是 PAT 的重要组成部分，因此该评论讨论了常用的数据分析技术，并讨论了随着多个传感器的组合在该领域的发展而提出的数据融合方法。最后一章将对光谱方法与化学计量学和模型预测控制（MPC）相结合在下游过程中的应用进行展望。