用于检测免疫亲和色谱基质中单克隆抗体泄漏的酶联免疫吸附测定（ELISA）的开发。

Development of enzyme-linked immunosorbent assays (ELISAs) for the detection of monoclonal antibody leakage from immunoaffinity chromatography matrices.

作者信息

Beer D J, Yates A M, Jack G W

机构信息

Division of Biotechnology, Centre for Applied Microbiology and Research, Salisbury, Wiltshire, UK.

出版信息

J Immunol Methods. 1994 Jul 12;173(1):103-9. doi: 10.1016/0022-1759(94)90287-9.

DOI:10.1016/0022-1759(94)90287-9

PMID:8034977

Abstract

Antibodies can leak from immunoaffinity chromatography (IAC) matrices, reducing the working life of the IAC matrix and/or compromising the purity of the product, purified by IAC, for therapeutic use. There is therefore a need to monitor the leakage of antibody from IAC matrices. Antibody leakage from a model IAC system was measured using two-site 'non-competitive' ELISAs. Two assays were developed to measure the leakage of intact and fragmented antibody from the IAC matrix. By measuring the leakage of intact and fragmented antibody the mechanisms underlying antibody leakage from solid-supports could be elucidated.

摘要

抗体可能会从免疫亲和色谱（IAC）基质中泄漏出来，从而缩短IAC基质的使用寿命和/或影响经IAC纯化用于治疗的产品的纯度。因此，有必要监测抗体从IAC基质中的泄漏情况。使用双位点“非竞争性”酶联免疫吸附测定（ELISA）来测量抗体从模型IAC系统中的泄漏量。开发了两种测定方法来测量完整抗体和片段化抗体从IAC基质中的泄漏量。通过测量完整抗体和片段化抗体的泄漏量，可以阐明抗体从固体支持物中泄漏的潜在机制。