在生物反应器扩展和工艺转移中,使用根据不同通风孔大小的动态初始vvm的新策略
Huaping Ding1,2, Huanghe Cheng3, Jiaxian Wu2
1Department of Biomedical Engineering and Health Sciences, Faculty of Electrical Engineering, Universiti Teknologi Malaysia, Skudai, Johor, Malaysia.
Frontiers in bioengineering and biotechnology
|September 25, 2024
概括
这项研究通过将生物反应器的通风孔大小与每分钟初始通风量 (vvm) 联系起来,简化了单克隆抗体药物生产规模的扩大. 找到了最佳条件,提高了技术转让和生产效率.
科学领域:
- 生物技术是生物技术.
- 化学工程是化学工程的重要组成部分.
- 制药制造业 制药制造业 制药制造业
背景情况:
- 不断增长的单克隆抗体市场需要高效的生产,但不同的药物需求和生物反应器变异挑战了扩大规模.
- 传统的扩展策略 (恒定功率/体积和vvm) 由于一次性生物反应器的通风孔尺寸不一致,是不够的.
研究的目的:
- 通过专注于通风孔大小,开发一种简化,优化的生物反应器参数选择.
- 建立空气孔大小,初始空气vm和功率/体积 (P/V) 之间的定量关系,以改进技术转让和扩展.
主要方法:
- 设计实验 (DoE) 使用直角测试来研究P/V,vvm和通风孔径大小之间的关系.
- 确定了特定的空气孔大小范围内的特定空气孔大小范围的最佳初始空气率,在定义的P/V范围内.
- 在15L和500L生物反应器中验证的发现.
主要成果:
- 在20 ± 5W/m3的P/V范围内,在通风孔大小和初始通风vm之间建立了定量关系.
- 最佳初始通风量被确定为0.010.005 m3/min,通风孔大小为10.3 mm.
- 最初的通风策略显著影响了最终产品的表达.
结论:
- 透气孔的大小是优化生物反应器条件和扩大规模的关键因素.
- 建立的定量关系为改进技术转让和高效的单克隆抗体生产提供了基础.
- 这项研究为选择最佳生物反应器参数提供了实际指导方针,提高了生产的一致性和产量.
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