Choices of capture chromatography technology in antibody manufacturing processes

被引:13
作者
Dileo, Michael [1 ]
Ley, Arthur [1 ]
Nixon, Andrew E. [1 ]
Chen, Jie [1 ]
机构
[1] Dyax Corp, Proc Sci, Discovery Res, 55 Network Dr, Burlington, MA 01803 USA
来源
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES | 2017年 / 1068卷
关键词
Capture chromatography technology; Protein A chromatography; Cation exchange chromatography; Mixed mode chromatography; Monoclonal antibody manufacturing process; MONOCLONAL-ANTIBODIES; PURIFICATION;
D O I
10.1016/j.jchromb.2017.09.050
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
The capture process employed in monoclonal antibody downstream purification is not only the most critically impacted process by increased antibody titer resulting from optimized mammalian cell culture expression systems, but also the most important purification step in determining overall process throughput, product quality, and economics. Advances in separation technology for capturing antibodies from complex feedstocks have been one focus of downstream purification process innovation for past 10 years. In this study, we evaluated new generation chromatography resins used in the antibody capture process including Protein A, cation exchange, and mixed mode chromatography to address the benefits and unique challenges posed by each chromatography approach. Our results demonstrate the benefit of improved binding capacity of new generation Protein A resins, address the concern of high concentration surge caused aggregation when using new generation cation exchange resins with over 100 mg/mL binding capacity, and highlight the potential of multimodal cation exchange resins for capture process design. The new landscape of capture chromatography technologies provides options to achieve overall downstream purification outcome with high product quality and process efficiency.
引用
收藏
页码:136 / 148
页数:13
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