Does interaction of monoclonal antibody charge variants with VEGF-A and ELISA reagents affect its quantification?

被引：11

作者：

Sreenivasan, Shravan ^{[1
]}

Kumar, Deepak ^{[1
]}

Malani, Himanshu ^{[1
]}

Rathore, Anurag S. ^{[1
]}

机构：

[1] Indian Inst Technol Delhi, Dept Chem Engn, New Delhi 110016, India

来源：

ANALYTICAL BIOCHEMISTRY | 2020年 / 590卷

关键词：

Monoclonal antibodies; ELISA; Serum; Pharmacokinetics; BINDING; CHROMATOGRAPHY; VALIDATION; SEPARATION; GRADIENT;

D O I：

10.1016/j.ab.2019.113513

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The ability of an enzyme linked immunosorbent assay (ELISA) to measure the concentration of charge variants of a monoclonal antibody (mAb) biotherapeutic has been investigated. Percentage recovery was found to be in the range of 80%-120% with inter and intra assay variation between 5% and 15%. Linear regression analysis of ELISA output at different dilutions yielded a good fit (R-2 > 0.98). Assay output was not hindered by the presence of serum proteins and other analytes such as GCSF, demonstrating acceptable precision and specificity. It was concluded that the charge variants of the mAb can be accurately quantified by ELISA.

引用

页数：6

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