Optimisation of high value biopharmaceuticals Manufacture using Resonant Raman Observations

在酶和单克隆抗体等高价值生物药品的生产过程中，小的产量损失（<1%）对生产者具有相当大的商业影响。需要开发实时分析工具来优化产量，最大限度地减少过程中损失，提高产品一致性并降低下游处理（DSP）期间的成本。本课题旨在设计并实现一种新的光谱分析工具，用于DSP的定量分析与控制。该项目将应用该技术来帮助优化需要高灵敏度和选择性的DSP，以提高色谱分离（DSP纯化的主要工具）。将开发软件来监控UVRRS提供的实时数据，并为当前和未来的馏分收集输出最佳参数，从而使产量至少提高2% - 5%。

Small yield losses (<1%) during production of high value biopharmaceuticals such as enzymes and monoclonal antibodies have considerable commercial impact for producers. There is a need to develop real-time analytical tools to optimise yield, minimise in-process losses, increase product consistency and reduce cost during down-stream processing (DSP). The project aims to design and implement new spectral analysis tool for quantitative analysis and control of DSP. The project will apply the technology to help optimise DSP where high sensitivity and selectivity are required to improve chromatographic separation (the principal tool for DSP purification). Software will be developed to monitor real time data feeds from the UVRRS and output the optimal parameters for current and future fraction collection, delivering at least 2 % - 5% higher yields.