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Evolving trends in mAb production processes

机译：mAb生产工艺的发展趋势

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Monoclonal antibodies (mAbs) have established themselves as the leading biopharmaceutical therapeutic modality. The establishment of robust manufacturing platforms are key for antibody drug discovery efforts to seamlessly translate into clinical and commercial successes. Several drivers are influencing the design of mAb manufacturing processes. The advent of biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. High titers are now routinely achieved for mAbs in mammalian cell culture. These drivers have resulted in significant evolution in process platform approaches. Additionally, several new trends in bioprocessing have arisen in keeping with these needs. These include the consideration of alternative expression systems, continuous biomanufacturing and non‐chromatographic separation formats. This paper discusses these drivers in the context of the kinds of changes they are driving in mAb production processes.
机译：单克隆抗体（mAb）已将自己确立为主要的生物药物治疗手段。强大的制造平台的建立对于抗体药物发现努力无缝转化为临床和商业成功的关键。几个驱动因素正在影响mAb制造工艺的设计。生物仿制药的出现驱使人们实现降低商品成本并使生物制剂生产全球化的愿望。现在，在哺乳动物细胞培养中，mAb的常规滴度通常很高。这些驱动因素导致了流程平台方法的重大发展。另外，随着这些需求，生物加工中出现了一些新趋势。这些包括考虑替代表达系统，连续生物制造和非色谱分离格式。本文将在mAb生产过程中驱动的各种变化的背景下讨论这些驱动因素。

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