摘要
生物制药作为现代医药工业的重要组成部分，其生产工艺的优化与创新对提高药物质量和生产效率具有重要意义。本研究以生物技术为核心，针对当前生物制药工艺中存在的瓶颈问题，旨在开发高效、稳定且经济可行的生产方案。研究通过整合基因工程技术、细胞培养技术和分离纯化技术，设计了一种新型的重组蛋白表达系统，并结合高通量筛选方法，显著提升了目标产物的表达水平和纯度。同时，引入了智能化控制策略，实现了对关键工艺参数的精准调控，从而有效降低了生产成本并提高了批间一致性。实验结果表明，该工艺在表达效率、产物收率及质量稳定性等方面均优于传统方法，特别是在大规模生产条件下表现出优异的可扩展性。本研究的主要创新点在于将多学科技术融合应用于生物制药工艺优化，并首次提出了一种基于数据驱动的动态调控模型，为未来生物制药行业的技术升级提供了新思路。研究成果不仅有助于推动生物制药领域的技术进步，也为相关产业的可持续发展奠定了坚实基础。
关键词：生物制药工艺优化；重组蛋白表达系统；高通量筛选；智能化控制策略；数据驱动动态调控模型
Abstract
Biopharmaceuticals, as a crucial component of modern pharmaceutical industry, play an essential role in improving drug quality and production efficiency through process optimization and innovation. This study focuses on addressing the bottleneck issues in current biopharmaceutical manufacturing by developing a highly efficient, stable, and economically viable production strategy centered on biotechnology. By integrating gene engineering, cell culture technology, and separation/purification techniques, a novel recombinant protein ex pression system was designed, which, combined with high-throughput screening methods, significantly enhanced the ex pression level and purity of the target product. Furthermore, an intelligent control strategy was introduced to achieve precise regulation of key process parameters, effectively reducing production costs while improving batch-to-batch consistency. Experimental results demonstrated that this process outperforms traditional methods in terms of ex pression efficiency, product yield, and quality stability, particularly exhibiting excellent scalability under large-scale production conditions. The primary innovation of this research lies in the interdisciplinary integration of technologies for biopharmaceutical process optimization and the first-time proposal of a data-driven dynamic control model, offering new insights into technological upgrades in the biopharmaceutical industry. These findings not only contribute to advancing technical progress in the biopharmaceutical field but also lay a solid foundation for the sustainable development of related industries.
Keywords：Biopharmaceutical Process Optimization; Recombinant Protein ex pression System; High-Throughput Screening; Intelligent Control Strategy; Data-Driven Dynamic Regulation Model
目 录
摘要 I
Abstract II
一、绪论 1
(一) 生物制药工艺的研究背景与意义 1
(二) 国内外研究现状分析 1
(三) 本文研究方法与技术路线 2
二、生物制药生产工艺的关键技术分析 2
(一) 基因工程技术在生物制药中的应用 2
(二) 细胞培养技术的优化策略 3
(三) 发酵工艺参数的控制与改进 3
三、生物制药生产过程的质量控制研究 4
(一) 质量控制体系的构建与实施 4
(二) 关键质量属性的监测与分析 4
(三) 在线检测技术的应用与发展 5
四、生物制药生产工艺的效率提升与成本优化 5
(一) 工艺流程的系统化设计 5
(二) 成本控制的关键环节分析 6
(三) 绿色制造理念下的工艺改进 7
结 论 8
参考文献 9
