Department of Biotechnology, Koneru Lakshmaiah Education Foundation (KLEF), Vaddeswaram 522502, Guntur, Andhra Pradesh, INDIA.
Department of Biotechnology, Vignan's (Deemed to be) University, Guntur 522213, AP, India.
Gene. 2024 Oct 20;925:148607. doi: 10.1016/j.gene.2024.148607. Epub 2024 May 24.
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.
单克隆抗体(mAbs)被广泛用于预防、检测和治疗各种恶性肿瘤以及传染性和自身免疫性疾病。在过去的几年中,mAbs 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 mAbs 正在进行临床试验。自从杂交瘤技术问世以来,抗体治疗剂一直使用鼠源抗体来实现,进一步发展为人源化和全人源抗体,降低了免疫原性风险。与传统药物相比,使用 mAbs 的一些好处包括大大降低不良反应、药物相互作用和靶向特定蛋白质的风险。虽然 mAbs 非常有效,但它们较高的生产成本阻碍了商业化进程。然而,通过开发可负担得起的治疗性抗体的生物类似物,提高了它们的成本效益。除了生物类似物外,抗体工程的创新也有助于设计比传统抗体具有更好疗效的生物改良抗体。这些新型 mAb 治疗剂有望彻底改变针对广泛疾病的现有药物治疗方法,从而满足多种未满足的医疗需求。在未来,应用下一代测序(NGS)生成的 mAbs 有望成为临床治疗的有力工具。本文介绍了 mAb 生产方法、mAb 的临床前和临床开发、mAb 针对的已批准适应症以及 mAb 研究领域的新进展。