Karbyshev Mikhail S, Kalashnikova Irina V, Dubrovskaya Viktoriya V, Baskakova Kristina O, Kuzmichev Pavel K, Sandig Volker
Department of Biotechnology, Moscow Polytechnic University (Moscow Polytech), Moscow, Russia; Department of Biochemistry and Molecular Biology, Pirogov Russian National Research Medical University, Moscow, Russia.
Independent Researcher, Lexington, USA.
J Chromatogr A. 2025 Mar 15;1744:465722. doi: 10.1016/j.chroma.2025.465722. Epub 2025 Jan 25.
Bispecific antibodies (bsAbs) represent a rapidly growing field of therapeutic agents. More bsAbs are being approved worldwide and are in various stages of clinical trials. However, the discovery and production of novel bsAbs presents significant challenges due to their complex structure. Thus, precise control of assembly and stability is required, given the many formats developed. This review examines recent trends in bsAb production, focusing on advancements in engineering platforms, production strategies, and challenges in large-scale manufacturing. Key developments include improvements in modular antibody design, novel expression systems, and optimization of bioprocessing techniques to enhance stability, yield, and efficacy. Additionally, the article explores the future potential of bsAbs as next-generation therapeutics, underscoring the growing impact of these innovations on expanding treatment options for patients with unmet medical needs.
双特异性抗体（bsAbs）是一个快速发展的治疗药物领域。全球范围内有越来越多的双特异性抗体获批，并且处于临床试验的各个阶段。然而，由于其结构复杂，新型双特异性抗体的发现和生产面临重大挑战。因此，鉴于已开发出多种形式，需要对组装和稳定性进行精确控制。本综述考察了双特异性抗体生产的最新趋势，重点关注工程平台的进展、生产策略以及大规模制造中的挑战。关键进展包括模块化抗体设计的改进、新型表达系统以及生物加工技术的优化，以提高稳定性、产量和疗效。此外，本文探讨了双特异性抗体作为下一代治疗药物的未来潜力，强调了这些创新对扩大未满足医疗需求患者治疗选择的日益增长的影响。
