Fundamental properties and principal areas of focus in antibody-drug conjugates formulation development.

Q2 Medicine
Antibody Therapeutics Pub Date : 2025-03-09 eCollection Date: 2025-04-01 DOI:10.1093/abt/tbaf005
Lili Wen, Yuanyuan Zhang, Chenxi Sun, Shawn Shouye Wang, Yuhui Gong, Chunyuan Jia, Jianjun Luo
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引用次数: 0

Abstract

Antibody-drug conjugates (ADCs) have emerged as a rapidly expanding class of therapeutics driven by their superior specificity and clinical efficacy. 14 out of 16 commercially approved ADCs are formulated as lyophilized forms because ADC is generally considered to be less stable than unmodified antibody. The formulation development for ADCs, particularly liquid formulation, presents unique challenges due to their intricate structural complexity, physicochemical properties, and degradation pathways. This review provides the first comprehensive analysis of formulation strategies employed in commercial ADCs. Furthermore, this review discusses the key areas of focus for ADCs throughout the formulation development workflow, spanning from the initial formulation development to the final stage of drug product manufacturing. In addition, we identify and analyze the distinctive technical challenges in ADC formulation development compared to unconjugated antibody, while proposing potential solutions to these challenges. Finally, we offer strategic perspectives on future directions in ADC formulation development to advance this promising therapeutic modality.

抗体-药物偶联物配方开发的基本特性和主要关注领域。
抗体药物共轭物(ADC)因其卓越的特异性和临床疗效而成为一种迅速发展的治疗药物。由于 ADC 通常被认为不如未修饰的抗体稳定,因此在 16 种商业批准的 ADC 中,有 14 种是以冻干形式配制的。由于 ADC 的结构复杂、理化性质和降解途径各不相同,因此 ADC 的制剂开发,尤其是液体制剂的开发面临着独特的挑战。本综述首次对商业 ADC 采用的制剂策略进行了全面分析。此外,本综述还讨论了 ADC 在整个制剂开发工作流程中的重点领域,包括从最初的制剂开发到药物产品生产的最后阶段。此外,我们还确定并分析了 ADC 制剂开发与非结合抗体相比所面临的独特技术挑战,同时提出了应对这些挑战的潜在解决方案。最后,我们从战略角度展望了 ADC 制剂开发的未来方向,以推动这一前景广阔的治疗模式的发展。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Antibody Therapeutics
Antibody Therapeutics Medicine-Immunology and Allergy
CiteScore
8.70
自引率
0.00%
发文量
30
审稿时长
8 weeks
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