单克隆抗体的色谱纯化:提高纯度和回收率。

IF 4.1 Q2 PHARMACOLOGY & PHARMACY
Advanced pharmaceutical bulletin Pub Date : 2025-01-05 eCollection Date: 2025-04-01 DOI:10.34172/apb.43967
Elnazalsadat Jafarzadeh Chehraghi, Parvin Akbarzadehlaleh, Karim Shamsasenjan
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引用次数: 0

摘要

单克隆抗体由于其精确的靶向性和治疗潜力,在生物制药研究和生产中具有越来越重要的意义。单克隆抗体的纯化是生产的关键阶段,确保消除杂质,获得高质量,安全和高效的最终产品。包括亲和层析、离子交换层析和疏水相互作用层析(HIC)在内的色谱方法通常用于利用其独特的性质,如抗原结合特异性或表面电荷和疏水性,从复杂混合物中选择性地捕获和纯化单克隆抗体。本文综述了目前用于单克隆抗体纯化的色谱技术,并深入探讨了单克隆抗体纯化的最新进展和新趋势,包括多模态配体、膜吸附剂和连续处理的应用。这些创新旨在提高效率、选择性和可靠性,同时减少处理时间和成本,最终有助于开发安全有效的基于单克隆抗体的治疗方法。重点是根据单抗的独特性质和最终产品的期望质量属性选择合适的方法的必要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Purification of Monoclonal Antibodies Using Chromatographic Methods: Increasing Purity and Recovery.

Monoclonal antibodies (mAbs) have gained increasing significance in biopharmaceutical research and production because of their precise targeting and therapeutic potential. The purification of mAbs is a crucial stage in production, ensuring the elimination of impurities for a top-quality, safe, and efficient final product. Chromatographic methods including affinity chromatography, ion exchange chromatography, and hydrophobic interaction chromatography (HIC) are commonly utilized to selectively capture and purify mAbs from complex mixtures by exploiting their unique properties, such as antigen-binding specificity or their surface charge and hydrophobicity. This review provides an overview of the current chromatographic techniques for mAbs purification, and to this aim delves into recent advancements and emerging trends in mAb purification, including the application of multi-modal ligands, membrane adsorbers, and continuous processing. These innovations aim to enhance efficiency, selectivity, and reliability while reducing processing time and costs, ultimately contributing to the development of safe and effective mAb-based therapies. Emphasis is placed on the necessity of choosing suitable methods based on the unique properties of the mAb and the desired quality attributes of the end product.

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来源期刊
Advanced pharmaceutical bulletin
Advanced pharmaceutical bulletin PHARMACOLOGY & PHARMACY-
CiteScore
6.80
自引率
2.80%
发文量
51
审稿时长
12 weeks
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