Host cell proteins in monoclonal antibody processing: Control, detection, and removal

IF 2.5 3区 生物学 Q3 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Biotechnology Progress Pub Date : 2024-03-13 DOI:10.1002/btpr.3448
Takao Ito, Herb Lutz, Lihan Tan, Bin Wang, Janice Tan, Masum Patel, Lance Chen, Yuki Tsunakawa, Byunghyun Park, Subhasis Banerjee
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Abstract

Host cell proteins (HCPs) are process-related impurities in a therapeutic protein expressed using cell culture technology. This review presents biopharmaceutical industry trends in terms of both HCPs in the bioprocessing of monoclonal antibodies (mAbs) and the capabilities for HCP clearance by downstream unit operations. A comprehensive assessment of currently implemented and emerging technologies in the manufacturing processes with extensive references was performed. Meta-analyses of published downstream data were conducted to identify trends. Improved analytical methods and understanding of “high-risk” HCPs lead to more robust manufacturing processes and higher-quality therapeutics. The trend of higher cell density cultures leads to both higher mAb expression and higher HCP levels. However, HCP levels can be significantly reduced with improvements in operations, resulting in similar concentrations of approx. 10 ppm HCPs. There are no differences in the performance of HCP clearance between recent enhanced downstream operations and traditional batch processing. This review includes best practices for developing improved processes.

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单克隆抗体加工过程中的宿主细胞蛋白:控制、检测和清除。
宿主细胞蛋白 (HCP) 是利用细胞培养技术表达的治疗性蛋白质中与工艺相关的杂质。本综述从单克隆抗体 (mAbs) 生物工艺中的 HCP 以及下游单元操作清除 HCP 的能力两方面介绍了生物制药行业的发展趋势。对生产流程中目前采用的技术和新兴技术进行了全面评估,并提供了大量参考资料。对已公布的下游数据进行了元分析,以确定趋势。分析方法的改进和对 "高风险 "HCP 的了解,使生产流程更稳健,治疗药物的质量更高。细胞培养密度越高,mAb 表达量和 HCP 水平也就越高。不过,随着操作的改进,HCP 含量可大幅降低,从而使 HCP 的浓度保持在 10 ppm 左右。最近改进的下游操作与传统的批量处理在清除 HCP 的性能上没有差异。本次审查包括开发改进流程的最佳实践。
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来源期刊
Biotechnology Progress
Biotechnology Progress 工程技术-生物工程与应用微生物
CiteScore
6.50
自引率
3.40%
发文量
83
审稿时长
4 months
期刊介绍: Biotechnology Progress , an official, bimonthly publication of the American Institute of Chemical Engineers and its technological community, the Society for Biological Engineering, features peer-reviewed research articles, reviews, and descriptions of emerging techniques for the development and design of new processes, products, and devices for the biotechnology, biopharmaceutical and bioprocess industries. Widespread interest includes application of biological and engineering principles in fields such as applied cellular physiology and metabolic engineering, biocatalysis and bioreactor design, bioseparations and downstream processing, cell culture and tissue engineering, biosensors and process control, bioinformatics and systems biology, biomaterials and artificial organs, stem cell biology and genetics, and plant biology and food science. Manuscripts concerning the design of related processes, products, or devices are also encouraged. Four types of manuscripts are printed in the Journal: Research Papers, Topical or Review Papers, Letters to the Editor, and R & D Notes.
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