Alanazi Jouri, Aleanizy Fadilah Sfouq, Alqahtani Fulwah Yahya
Drug Sector, Saudi FDA, Riyadh 13513, Saudi Arabia.
Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11495, Saudi Arabia.
Pharmaceutics. 2025 Jul 7;17(7):888. doi: 10.3390/pharmaceutics17070888.
Biologic therapeutics, particularly monoclonal antibodies (mAbs), have revolutionized disease treatment paradigms; however, their clinical success is often hindered by immunogenicity. Host immune recognition of these biologics can induce anti-drug antibody (ADA) formation, leading to reduced therapeutic efficacy, altered pharmacokinetics and serious adverse events, such as infusion reactions and loss of response. Overcoming these immunogenicity challenges is essential to maximize the clinical effect of biologics and ensure patient safety. This paper offers an overview of the mechanisms underlying the formation of anti-drug antibodies and explores potential nanotechnology-based strategies to reduce or eliminate these responses. Specifically, the review examines how the immune system recognizes biologics and develops ADAs, which can impact drug efficacy and safety. The review then investigates various nanotechnology approaches aimed at mitigating ADA formation, potentially improving the therapeutic outcomes of biologic drugs.
生物治疗药物，尤其是单克隆抗体（mAb），已经彻底改变了疾病治疗模式；然而，它们的临床成功常常受到免疫原性的阻碍。宿主对这些生物药物的免疫识别可诱导抗药物抗体（ADA）形成，导致治疗效果降低、药代动力学改变以及严重不良事件，如输液反应和反应丧失。克服这些免疫原性挑战对于最大化生物药物的临床效果和确保患者安全至关重要。本文概述了抗药物抗体形成的潜在机制，并探讨了基于纳米技术的潜在策略以减少或消除这些反应。具体而言，该综述研究了免疫系统如何识别生物药物并产生ADA，这可能影响药物疗效和安全性。然后，该综述研究了各种旨在减轻ADA形成的纳米技术方法，这可能改善生物药物的治疗效果。
