Abstract：
Monoclonal antibodies (mAbs) are being used to prevent, detect, and treat a broad spectrum of malignancies and infectious and autoimmune diseases. Over the past few years, the market for mAbs has grown exponentially. They have become a significant part of many pharmaceutical product lines, and more than 250 therapeutic mAbs are undergoing clinical trials. Ever since the advent of hybridoma technology, antibody-based therapeutics were realized using murine antibodies which further progressed into humanized and fully human antibodies, reducing the risk of immunogenicity. Some of the benefits of using mAbs over conventional drugs include a drastic reduction in the chances of adverse reactions, interactions between drugs, and targeting specific proteins. While antibodies are very efficient, their higher production costs impede the process of commercialization. However, their cost factor has been improved by developing biosimilar antibodies, which are affordable versions of therapeutic antibodies. Along with biosimilars, innovations in antibody engineering have helped to design bio-better antibodies with improved efficacy than the conventional ones. These novel mAb-based therapeutics are set to revolutionize existing drug therapies targeting a wide spectrum of diseases, thereby meeting several unmet medical needs. In the future, mAbs generated by applying next-generation sequencing (NGS) are expected to become a powerful tool in clinical therapeutics. This article describes the methods of mAb production, pre-clinical and clinical development of mAbs, approved indications targeted by mAbs, and novel developments in the field of mAb research.
摘要：
单克隆抗体(mAb)被用来预防,检测，治疗广泛的恶性肿瘤和感染及自身免疫性疾病。在过去的几年里，单克隆抗体的市场呈指数级增长。它们已成为许多制药产品线的重要组成部分，超过250种治疗性单克隆抗体正在接受临床试验。自从杂交瘤技术出现以来，使用鼠抗体实现了基于抗体的治疗，这些抗体进一步发展为人源化和完全人抗体，降低免疫原性的风险。与常规药物相比，使用单克隆抗体的一些好处包括显著减少不良反应的机会，药物之间的相互作用，靶向特定的蛋白质。虽然抗体非常有效，它们较高的生产成本阻碍了商业化进程。然而,他们的成本因素通过开发生物仿制药抗体得到了改善，这是治疗性抗体的负担得起的版本。除了生物仿制药，抗体工程的创新有助于设计出生物更好的抗体，其功效比传统抗体更好。这些基于单克隆抗体的新型疗法将彻底改变针对广泛疾病的现有药物疗法，从而满足一些未满足的医疗需求。在未来,通过应用下一代测序（NGS）产生的mAb有望成为临床治疗中的有力工具。本文介绍了mAb的生产方法,单克隆抗体的临床前和临床发展，以单克隆抗体为目标的批准适应症，以及mAb研究领域的新进展。
