高性能反流膜净化用于从单克隆抗体产品中去除宿主细胞蛋白质
Aylin Mohammadzadehmarandi1, Amy Determan2, Christian Krumm2
1Department of Chemical Engineering, The Pennsylvania State University, University Park, Pennsylvania, USA.
Biotechnology and bioengineering
|August 18, 2023
概括
高性能反流膜净化 (HPCMP) 有效地从单克隆抗体产品中去除宿主细胞蛋白. 这种方法提供了高产量和稳定的运行,使其适合连续生物制造.
科学领域:
- 生物技术是生物技术.
- 生物加工是一种生物加工.
- 下游加工 下游加工
背景情况:
- 持续的生物制造需要高效的下游加工来净化单克隆抗体 (mAb).
- 宿主细胞蛋白 (HCP) 是关键的杂质,必须从治疗蛋白中去除.
研究的目的:
- 评估高性能反流膜净化 (HPCMP) 用于从中国仓鼠卵巢 (CHO) 细胞衍生的mAbs.去除HCPs.
- 评估HPCMP在mAb净化工作流程中的性能和稳定性.
主要方法:
- 使用模型蛋白质优化了空心纤维膜模块.
- 在mAb净化过程中,HPCMP被应用到mAb净化过程中,使用染色学澄清器预先过了料.
- 过程质量强度 (PMI) 与其他HCP分离方法进行了比较.
主要成果:
- HPCMP实现了超过95%的mAb收益率.
- 观察到HCP减少了100倍以上.
- 稳定的HPCMP运行在预过料下维持了48小时.
- 与其他HCP删除技术相比,HPCMP显示了潜在的较低的过程质量强度.
结论:
- 在mAb净化中,HPCMP是一种有前途的技术,可以有效地去除HCP.
- 该方法支持稳定,连续运行,适合集成生物制造工艺.
- HPCMP提供了一个潜在的更可持续和更具成本效益的下游加工解决方案.
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