Howard P. Isermann Department of Chemical & Biological Engineering, Rensselaer Polytechnic Institute, Troy, NY, USA.
Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, Devens, MA, USA.
J Biotechnol. 2021 Sep 10;338:1-4. doi: 10.1016/j.jbiotec.2021.06.020. Epub 2021 Jun 29.
This paper describes a simplified affinity precipitation process for the purification of mAbs from complex mixtures using elastin-like polypeptide fused to a single Z domain of protein A (ELP-Z). This approach eliminates several steps in the original process by directly extracting the mAb from the affinity precipitate, without the need for resolubilization. The efficacy of this elution without resolubilization (EWR) approach for obtaining pure mAb is demonstrated and the effects of mixing are examined. This simplification of the affinity precipitation process may facilitate the implementation of ELP-Z based mAb bioprocessing, particularly in a continuous scenario.
本文描述了一种使用弹性蛋白样多肽融合到单个蛋白 A 的 Z 结构域(ELP-Z)的简化亲和沉淀工艺,用于从复杂混合物中纯化单抗。该方法通过直接从亲和沉淀中提取 mAb,无需复溶,省去了原始方法中的几个步骤。本文展示了这种不解离洗脱(EWR)方法获得纯 mAb 的效果,并考察了混合的影响。这种亲和沉淀工艺的简化可能有助于基于 ELP-Z 的 mAb 生物加工的实施,特别是在连续的情况下。