Precipitation is a key manufacturing unit during the immunoglobulin G (IgG) production, which guarantees the quality of the final product. Ethanol is usually used to purify IgG during the precipitation process, so it is important to monitor the ethanol concentration online. Near-infrared (NIR) spectroscopy is a powerful process analytical technology (PAT) which has been proved to be feasible to determine the ethanol concentration during the precipitation process. However, the NIR model is usually established based on the specific process, so a universal model is needed. And the clarity degree of solution will affect the quality of the spectra. Therefore, in this study an integrated NIR system was introduced to establish a universal NIR model which could predict the ethanol concentration online and determine the end-point of the whole process. First, a spectra acquisition device was designed and established in order to get high-quality NIR spectra. Then, a simple prepared ethanol NIR model was constructed to predict the actual manufacturing process. Finally, the end-point was determined to stop the peristaltic pump when the ethanol concentration reached 20%. The results showed that the spectra quality was good, model prediction was accurate, and process monitoring was accurate. In conclusion, all results indicated that the integrated NIR system could be used to monitor the biopharmaceutical process to help us understand the pharmaceutical process.

中文翻译：

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智能近红外光谱系统测定免疫球蛋白 G 沉淀终点

沉淀是免疫球蛋白 G (IgG) 生产过程中的关键制造单元，它保证了最终产品的质量。乙醇通常用于在沉淀过程中纯化 IgG，因此在线监测乙醇浓度非常重要。近红外 (NIR) 光谱是一种强大的过程分析技术 (PAT)，已被证明可用于确定沉淀过程中的乙醇浓度。但是 NIR 模型通常是根据具体过程建立的，因此需要一个通用的模型。而溶液的澄清程度会影响光谱的质量。因此，在本研究中，引入了一个集成的 NIR 系统来建立一个通用的 NIR 模型，该模型可以在线预测乙醇浓度并确定整个过程的终点。首先，为了获得高质量的近红外光谱，设计并建立了光谱采集装置。然后，构建了一个简单的制备乙醇 NIR 模型来预测实际制造过程。最后以乙醇浓度达到20%时停止蠕动泵为终点。结果表明，光谱质量好，模型预测准确，过程监控准确。总之，所有结果表明，集成 NIR 系统可用于监测生物制药过程，以帮助我们了解制药过程。以乙醇浓度达到20%时停止蠕动泵为终点。结果表明，光谱质量好，模型预测准确，过程监控准确。总之，所有结果表明，集成 NIR 系统可用于监测生物制药过程，以帮助我们了解制药过程。以乙醇浓度达到20%时停止蠕动泵为终点。结果表明，光谱质量好，模型预测准确，过程监控准确。总之，所有结果表明，集成 NIR 系统可用于监测生物制药过程，以帮助我们了解制药过程。