过程优化和扩大复合原-弹性蛋白融合蛋白高效生物合成的规模
Luping Zhou1, Jianwei Xiong1, Longying Liu1
1Ganjiang Chinese Medicine Innovation Center, Nanchang 330000, China.
International journal of biological macromolecules
|July 13, 2025
概括
工程细菌高效地产生原-弹性质融合蛋白 (CEPs) 用于再生医学. 可扩展的生产和净化产生高纯度的CEP,具有出色的生物安全性和伤口愈合特性.
科学领域:
- 生物材料科学 生物材料科学
- 生物技术是生物技术.
- 再生医学是一种再生医学.
背景情况:
- 原蛋白和弹性蛋白是细胞外矩阵的关键组成部分,具有出色的生物相容性和生物降解性,使它们成为有前途的生物材料.
- 原-弹性蛋白融合蛋白 (CEPs) 在组织再生方面显示出潜力,但面临着生产可扩展性的挑战.
研究的目的:
- 开发一种可扩展和高效的再生原-弹性蛋白融合蛋白 (CEP) 生产工艺.
- 为CEP在再生医学中的工业应用优化发酵和净化方法.
主要方法:
- 设计了一种高效CEP表达的细菌菌株.
- 使用单因素和响应表面方法 (RSM) 优化发酵参数.
- 在5L生物反应器中验证了该过程,并扩展到500L试点系统,并进行多步净化 (花化,离子交换色谱).
主要成果:
- 达到4.68g/L的最大发酵产量.
- 试验规模的发酵产量与小规模的结果相当.
- 纯化CEP达到98%的纯度和72.60%的回收.
- 与商业原相比,体外和体内研究表明,与商业原相比,生物安全性良好,伤口愈合改善.
结论:
- 建立了CEP生产的强大,可扩展的发酵和净化过程.
- 证明了纯化CEP在再生医学的工业应用中的潜力,特别是伤口愈合.
- 提供了CEP从实验室转化为临床使用的关键技术参数.
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