生物制药过程中发酵工艺的优化研究 -制药工程专业

摘要

生物制药过程中，发酵工艺的优化是提高药物产量和质量的关键环节。随着基因工程和代谢工程技术的快速发展，传统发酵工艺已难以满足现代生物制药的需求。本研究旨在通过系统性优化策略，提升目标药物的发酵效率和产量。研究首先对现有发酵工艺进行全面分析，发现其主要瓶颈在于菌株代谢途径的限制和发酵条件的非最优化。基于此，我们采用多层次优化方法，包括菌株改造、培养基优化和发酵过程控制。通过基因编辑技术对目标菌株进行代谢途径改造，显著提高了其对底物的利用效率；同时，利用响应面法对培养基成分进行优化，确定了最佳碳源、氮源及微量元素配比。在发酵过程控制方面，引入智能控制系统实时监测并调整温度、pH值和溶氧等关键参数，确保发酵过程的稳定性。实验结果表明，经过优化的发酵工艺使目标药物产量提高了35%，且产品质量显著提升。

关键词：发酵工艺优化；基因编辑技术；智能控制系统；生物制药

OPTIMIZATION OF FERMENTATION PROCESS IN BIOPHARMACEUTICAL PROCESS

ABSTRACT

In the process of biopharmaceutical, the optimization of fermentation process is the key link to improve the yield and quality of drugs. With the rapid development of genetic engineering and me tabolic engineering technology, the traditional fermentation process has been difficult to meet the needs of modern biopharmaceutical. The aim of this study was to improve the fermentation efficiency and yield of target drugs through systematic optimization strategies. Firstly, the existing fermentation process was comprehensively analyzed, and the main bottleneck was found to be the restriction of me tabolic pathway and the non-optimization of fermentation conditions. Based on this, we adopted a multi-level optimization method, including strain modification, medium optimization and fermentation process control. The me tabolic pathway of the target strain was modified by gene editing technology, and the utilization efficiency of the substrate was significantly improved. At the same time, the response surface method was used to optimize the composition of the medium, and the best carbon source, nitrogen source and trace element ratio were determined. In terms of fermentation process control, an intelligent control system is introduced to monitor and adjust key parameters such as temperature, pH value and dissolved oxygen in real time to ensure the stability of the fermentation process. The experimental results showed that the optimized fermentation process increased the yield of target drug by 35%, and the product quality was significantly improved.

KEY WORDS：Fermentation Process Optimization; Gene Editing Technology; Intelligent Control System; Biopharma

摘要 I

ABSTRACT II

第1章绪论 2

1.1 研究背景及意义 2

1.2 生物制药发酵工艺优化研究现状 2

1.3 本文研究方法与技术路线 3

第2章发酵工艺参数的优化策略 4

2.1 温度对发酵过程的影响及优化 4

2.2 pH值调控对发酵效率的作用分析 4

2.3 溶氧水平对微生物代谢的影响及优化措施 5

第3章发酵过程中微生物代谢调控的研究 6