Department of Chemical Engineering, The Pennsylvania State University, University Park, Pennsylvania, USA.
3M Separation and Purification Sciences, St. Paul, Minnesota, USA.
Biotechnol Bioeng. 2023 Dec;120(12):3585-3591. doi: 10.1002/bit.28531. Epub 2023 Aug 18.
The transition to continuous biomanufacturing has led to renewed interest in alternative approaches for downstream processing of monoclonal antibody (mAb) products. In this study, we examined the potential of using high-performance countercurrent membrane purification (HPCMP) for the removal of host cell proteins (HCPs) derived from Chinese Hamster Ovary cells in the purification of a mAb. Initial studies used several model proteins to identify appropriate operating conditions for the hollow fiber membrane modules. HPCMP was then used for mAb purification, with mAb yield >95% and more than 100-fold reduction in HCP. Stable operation was maintained for 48 h for feeds that were first prefiltered through the 3M Harvest RC chromatographic clarifier to remove DNA and other foulants. In addition, the Process Mass Intensity for HPCMP can be much less than that for alternative HCP separation processes. These results highlight the potential of using HPCMP as part of a fully continuous mAb production process.
向连续生物制造的转变促使人们重新关注单克隆抗体 (mAb) 产品下游处理的替代方法。在这项研究中，我们研究了使用高效逆流膜纯化 (HPCMP) 从中国仓鼠卵巢细胞中去除宿主细胞蛋白 (HCP) 的潜力，以纯化 mAb。初步研究使用了几种模型蛋白来确定中空纤维膜模块的合适操作条件。然后使用 HPCMP 进行 mAb 纯化，mAb 收率>95%，HCP 减少 100 倍以上。对于先通过 3M Harvest RC 层析澄清器预过滤以去除 DNA 和其他污染物的进料，可稳定运行 48 小时。此外，HPCMP 的过程质量强度可以远小于替代 HCP 分离过程。这些结果突出了 HPCMP 作为完全连续 mAb 生产过程的一部分的潜力。
