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一种使用 PCA 技术对关键试剂抗体进行系统且灵敏评估的方法。

A systematic and sensitive method for critical reagent antibody evaluation with PCA technology.

机构信息

Pharmaceutical & Biological Engineering Department, Zibo Vocational Institute, Zibo, Shandong, 255300, China.

Array Bridge Inc., 4340 Duncan Avenue, Suite 222, St. Louis, MO 63110, USA.

出版信息

Bioanalysis. 2022 Dec;14(23):1479-1486. doi: 10.4155/bio-2022-0195. Epub 2023 Feb 17.

DOI:10.4155/bio-2022-0195
PMID:36799240
Abstract

Quality control of critical reagents is essential in basic research and in drug discovery and development. Protein conformational array (PCA) is an ELISA-based technology that has been successfully used for the development of novel and biosimilar biologics with excellent sensitivity and accuracy. PCA ELISA is able to monitor higher order structure changes of mouse and rabbit antibodies under various stress and storage conditions. This study focused on the short- and long-term storage of antibodies and antiserum as well as the effect of multiple freeze-thaw cycles on the impact of antibody higher order structure. These results suggest that PCA ELISA can be used as a valuable method for quality testing of antibodies.

摘要

在基础研究和药物发现与开发中,关键试剂的质量控制至关重要。蛋白质构象阵列(PCA)是一种基于 ELISA 的技术,已成功用于新型和生物类似物生物制剂的开发,具有出色的灵敏度和准确性。PCA ELISA 能够监测在各种应激和储存条件下,小鼠和兔抗体的高级结构变化。本研究集中于抗体和抗血清的短期和长期储存,以及多次冻融循环对抗体高级结构影响的作用。这些结果表明,PCA ELISA 可以作为抗体质量检测的一种有价值的方法。

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