Quantitation of residual trypsin in cell-based therapeutics using immobilized α-1-antitrypsin or SBTI in an ELISA format

被引：14

作者：

Braatz, James A. ^{[1
]}

Elias, Christopher ^{[1
]}

Finny, Joseph G. ^{[1
]}

Huan Tran ^{[1
]}

McCaman, Michael ^{[1
]}

机构：

[1] Lonza Walkersville Inc, BioAssay Serv Dept, Walkersville, MD 21793 USA

来源：

JOURNAL OF IMMUNOLOGICAL METHODS | 2015年 / 417卷

关键词：

Porcine trypsin; alpha-1-Antitrypsin; ELISA; Cell-based therapeutic; Process residual; COMPLEXES; SCALE;

D O I：

10.1016/j.jim.2014.12.009

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

An Enzyme-Linked Immunosorbent Assay (ELISA) has been developed for the quantitation of porcine trypsin as a process residual in cell therapy products based on its capture by either of two immobilized anti-trypsins, alpha-1-antitrypsin (alpha(1)AT) or soybean trypsin inhibitor (SBTI) followed by detection with a polyclonal goat anti-porcine trypsin-IgG conjugated with peroxidase. It was demonstrated that an extended range of antigen quantitation could be achieved that covered nearly three orders of magnitude of trypsin concentration. The utility of the assay was demonstrated by its application to samples generated in a cell-based therapeutic manufacturing setting. (C) 2014 Elsevier B.V. All rights reserved.

引用

页码：131 / 133

页数：3

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