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首页> 外文期刊>Biotechnology Progress >Free Light Chain Content in Culture Media Reflects Recombinant Monoclonal Antibody Productivity and Quality
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Free Light Chain Content in Culture Media Reflects Recombinant Monoclonal Antibody Productivity and Quality

机译：培养基中的游离轻链含量反映了重组单克隆抗体的生产率和质量

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摘要

Monoclonal antibodies (mAbs) are currently the dominant class of biopharmaceuticals. Due to the high dosage requirements of most mAb therapeutics, high productivity and low aggregation are prevailing criteria during cell line generation and process development. Given that light chains (LCs) play an important role in antibody folding and assembly, and that most mAb producing cell lines also manufacture free LCs, we sought to investigate whether there was a relationship between free LC levels in cell culture media and mAb productivity/ quality. To this end, a series of analytical methods were developed in order to quantify free LC content in cell culture media and assess mAb productivity and aggregation levels. Afterwards, conditioned media samples from different cell lines at identical culturing conditions and a single clone under varying culturing conditions were analyzed. Higher LC expression was found to correlate with higher cell viability, higher mAb productivity, and lower aggregation. While LC expression cannot yet be definitively considered the root cause of these phenomena, these results are consistent with the role of LCs in mAb production, suggesting that free LC expression levels may potentially serve as a parameter for cell line generation and cell culture process optimization.
机译：单克隆抗体（mAbs）目前是生物药物的主要类别。由于大多数mAb治疗药物的高剂量要求，因此在细胞系生成和工艺开发过程中，高生产率和低聚集是主要标准。鉴于轻链（LC）在抗体折叠和组装中起着重要作用，并且大多数产生mAb的细胞系也产生游离LC，我们试图研究细胞培养基中的游离LC水平与mAb生产率/之间是否存在关系质量。为此，开发了一系列分析方法，以定量细胞培养基中的游离LC含量并评估mAb的生产率和聚集水平。然后，分析了在相同培养条件下来自不同细胞系的条件培养基样品以及在不同培养条件下的单个克隆。发现较高的LC表达与较高的细胞活力，较高的mAb生产率和较低的聚集相关。虽然尚不能确定地将LC表达视为这些现象的根本原因，但这些结果与LC在mAb产生中的作用相一致，这表明游离LC表达水平可能潜在地用作细胞系生成和细胞培养过程优化的参数。

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