Development of Peptide Ligands for Targeted Capture of Host Cell Proteins from Cell Culture Production Harvests.

Development of Peptide Ligands for Targeted Capture of Host Cell Proteins from Cell Culture Production Harvests.
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开发用于从细胞培养物生产收获物中靶向捕获宿主细胞蛋白的肽配体。

DOI:
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发表时间:
2021
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通讯作者:
S. Menegatti
S. Menegatti
中科院分区:
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作者:
R. A. Lavoie;T. Williams;R. K. Blackburn;R. Carbonell;S. Menegatti

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从细胞培养生产收获物中捕获宿主细胞蛋白(HCP)对于确保国际监管机构规定的治疗性单克隆抗体(mAb)产品纯度的最高水平至关重要。肽配体选择性靶向整个HCP谱,同时让mAb产物以未结合的形式流过,是通过蛋白A色谱进行的基于亲和力的捕获步骤的理想补充。在这项工作中,我们描述了HCP结合肽配体的开发,特别关注(1)通过文库筛选进行肽选择和(2)通过质谱法进行蛋白质组学定量HCP去除的步骤。
Capture of host cell proteins (HCPs) from cell culture production harvests is critical to ensure the maximum levels specified by international regulatory bodies of product purity for therapeutic monoclonal antibodies (mAbs). Peptide ligands that selectively target the whole spectrum of the HCPs, while letting the mAb product flow through unbound, are an ideal complement to the affinity-based capture step via Protein A chromatography. In this work, we describe the development of HCP-binding peptide ligands, especially focusing on the steps of (1) peptide selection via library screening and (2) quantification of HCP removal via proteomics by mass spectrometry.