四个时代的单克隆抗体疗法开发和生产的历史与潜在未来。

IF 5.6 2区医学 Q1 MEDICINE, RESEARCH & EXPERIMENTAL

mAbs Pub Date : 2024-01-01 Epub Date: 2024-07-01 DOI:10.1080/19420862.2024.2373330

Brian Kelley

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引用次数: 0

摘要

自 1986 年首次批准生产单克隆抗体（mAb）以来，治疗性单克隆抗体（mAb）的开发和药物物质的生产工艺不断发展。过去往往是未来的序幕，因此我们将这些技术的发展历程分为三个时代，从而推测下一个时代在开发和生产策略方面可能会发生的变化，以及对患者可能产生的影响。生产培养滴度和生物反应器产量的大幅提高，以及大规模合同生产设施的可用性，可能会改善这些疗法在全球范围内的可及性，并扩大治疗性抗体的适应症。

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The history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras.

Therapeutic monoclonal antibody (mAb) development and the processes for manufacturing drug substance have evolved since the first approval of the mAb in 1986. As the past is often the prologue to the future, the history of these technologies has been classified here into three eras, leading to speculation about what the next era may hold with regard to development and manufacturing strategies, as well as the potential impacts to patients. The substantial increase in production culture titers and bioreactor production volumes and the availability of large-scale contract manufacturing facilities could translate into improved global access for these therapies and an expansion of indications for therapeutic antibodies.

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来源期刊

mAbs 工程技术-仪器仪表

CiteScore

10.70

自引率

11.30%

发文量

审稿时长

6-12 weeks

期刊介绍： mAbs is a multi-disciplinary journal dedicated to the art and science of antibody research and development. The journal has a strong scientific and medical focus, but also strives to serve a broader readership. The articles are thus of interest to scientists, clinical researchers, and physicians, as well as the wider mAb community, including our readers involved in technology transfer, legal issues, investment, strategic planning and the regulation of therapeutics.