使用Ambr® 250高吞吐量并行生物反应器对mAb生产的CHO细胞培养的过程映射和优化研究
A Bordoloi1,2, F Talebnia Rowshan3,4
1Department of Sustainable Chemical, Biological and Materials Engineering, University of Oklahoma, Norman, 73019, USA.
Bioprocess and biosystems engineering
|August 30, 2025
概括
使用Ambr®250生物反应器优化中国仓鼠卵巢细胞培养加速了单克隆抗体 (mAb) 的产生. 精确了种植密度和养率等关键参数,显著提高了mAb标位和缩短时间表.
科学领域:
- 生物技术
- 生物处理工程
- 哺乳动物细胞培养
背景情况:
- 加速单克隆抗体 (mAb) 的产生对于患者及时获得治疗至关重要.
- 中国仓鼠卵巢 (CHO) 细胞是 mAb 生产的主要宿主.
- 高吞吐量 (HTP) 生物反应器系统为过程优化提供精确的控制.
研究的目的:
- 优化关键过程参数 (CPP) 以提高CHO细胞中的mAb产量.
- 利用Ambr®250 HTP生物反应器系统进行高效的过程开发.
- 建立一个加速早期生物工艺开发的框架.
主要方法:
- 系统地绘制地图来识别CPP.
- 在Ambr®250生物反应器中的中央复合设计 (CCD).
- 用于参数优化的响应表面方法.
主要成果:
- 种植密度 (SD) 和养速率 (FR) 对 mAb 标位产生显著影响.
- 确定最佳条件:SD> 1x10^6细胞/毫升和FR> 2%Vc/天.
- 达到高达5g/L的mAb标位,同时保持细胞活力和生产力.
结论:
- 针对SD和FR的优化操作范围提高了mAb的生产效率.
- Ambr®250平台为加速过程开发和可扩展制造提供了便利.
- 提高生产率和降低成本使患者更容易获得生物制剂.
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