Tecnologico de Monterrey, School of Engineering and Science, Monterrey, NL, Mexico.
J Sep Sci. 2019 May;42(9):1816-1827. doi: 10.1002/jssc.201800963. Epub 2019 Mar 21.
Antibodies for therapeutic use are being continuously approved and their demand has been steadily growing. As known, the golden standard for monoclonal antibody (mAb) purification is Protein A affinity chromatography, a technology that has gained high interest because of its great performance and capabilities. The main concerns are the elevated resins costs and their limited lifetime compared to other resins (e.g. ion exchange chromatography). Great efforts have been carried out to improve purification conditions, such as resin characterization and designing alkali/acid stable resins with a longer lifetime. Modification of Protein A ligands and alternative formats such as monoliths membranes and microshperes have been tested to increase the purification performance. New technology has been proposed to improve the large-scale separation; in addition, alternative ligands have been suggested to capture mAbs instead of Protein A ligand; however, most of the information is locked by pharmaceutical companies. This mini review summarizes and describes the advances, results, and impact on the Protein A chromatography purification processing.
治疗用抗体不断获得批准,其需求稳步增长。众所周知,单克隆抗体(mAb)纯化的金标准是 Protein A 亲和层析,由于其出色的性能和功能,该技术受到了广泛关注。人们主要关注的是与其他树脂(例如离子交换层析)相比,高树脂成本和有限的寿命。为了改善纯化条件,已经进行了大量的努力,例如树脂特性分析和设计具有更长寿命的碱性/酸性稳定树脂。已经测试了对 Protein A 配体的修饰和替代形式,例如整体柱膜和微球,以提高纯化性能。已经提出了新技术来改善大规模分离;此外,还提出了替代配体来代替 Protein A 配体捕获 mAb;但是,大部分信息被制药公司锁定。这篇迷你综述总结并描述了 Protein A 层析纯化处理方面的进展、结果和影响。
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