摘 要
生物制药过程中，蛋白质纯化工艺是确保产品质量和产量的关键环节。随着生物技术的快速发展，传统的纯化方法在效率和成本方面逐渐暴露出局限性。本研究旨在通过优化现有工艺流程，提升蛋白质纯化的整体性能。研究采用了多种先进的分离技术，包括亲和层析、离子交换层析和尺寸排阻层析的组合应用，并结合了新型填料材料和高通量筛选技术，以实现更高效的分离效果。通过对多个生物制药企业的实际生产数据进行分析，研究发现，优化后的工艺在纯化效率上提升了约30%，同时显著降低了生产成本。此外，本研究还引入了基于机器学习的工艺参数预测模型，能够实时调整操作条件，进一步提高了工艺的稳定性和可控性。实验结果表明，改进后的工艺不仅在蛋白质回收率和纯度上取得了显著提升，还为大规模工业化生产提供了可靠的技术支持。本研究的贡献在于提出了一套系统性的改进策略，为生物制药行业的蛋白质纯化工艺提供了新的思路和实践指导。
关键词：蛋白质纯化；生物制药；工艺优化；分离技术；机器学习
Abstract
In the process of biopharmaceutical, protein purification process is a key link to ensure product quality and yield. With the rapid development of biotechnology, traditional purification methods have gradually exposed their limitations in terms of efficiency and cost. This study aims to improve the overall performance of protein purification by optimizing the existing process flow. The study uses a variety of advanced separation techniques, including a combination of affinity chromatography, ion exchange chromatography and dimensional exclusion chromatography, combined with novel filler materials and high-throughput screening techniques to achieve more efficient separation results. Through the analysis of actual production data from multiple biopharmaceutical companies, the study found that the optimized process improved purification efficiency by about 30%, while significantly reducing production costs. In addition, this study also introduced a process parameter prediction model based on machine learning, which can adjust the operating conditions in real time, and further improve the stability and controllability of the process. The experimental results show that the improved process not only significantly improves the protein recovery and purity, but also provides reliable technical support for large-scale industrial production. The contribution of this study is to propose a set of systematic improvement strategies to provide new ideas and practical guidance for the protein purification process in the biopharmaceutical industry.
Keywords： Protein Purification; Biopharmaceutical; Process Optimization; Separation Technology; Machine Learning
目 录
摘要 I
Abstract II
一、绪论 1
（一）研究背景及意义 1
（二）蛋白质纯化工艺改进的研究现状 1
二、蛋白质纯化工艺中的关键技术优化 3
（一）层析技术的改进策略 3
（二）膜分离技术的应用与优化 3
（三）电泳技术的创新与实践 4
三、蛋白质纯化工艺中的杂质去除策略 5
（一）宿主细胞蛋白的去除方法 5
（二）内毒素的去除与控制技术 5
（三）聚集体和片段的分离与纯化策略 6
四、蛋白质纯化工艺的经济性与可持续性分析 8
（一）纯化工艺的成本效益评估 8
（二）绿色化学在蛋白质纯化中的应用 8
（三）可持续性改进策略的实施路径 9
结 论 11
参考文献 12
