Development of E.coli Host Cell Proteins generic ELISA and a Comparison with generic E.coli HCP ELISA available commercially

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作者

Kalpesh Jain¹

1. COO

会议/活动

Immunocon, January 2009 (虚拟会议)

海报摘要

New generation pharmaceuticals manufactured by the biotechnology route can be contaminated by residual host cell proteins during the cell culturing or fermentation stage. These proteins may cause an immune reaction in patients leading to manufacturers being advised to comply with these as per ICH and FDA guidelines. In the present study, we developed a generic version of an immunoassay to detect host cell proteins generated in E.coli. The antibodies used to manufacture the immunoassay were determined in view of the cell line frequently used for manufacturing. We also compared the sensitivity and specificity with alternate immunoassay kit available commercially.

关键词

Bioprocessing, Downstream processing, Expression system, E. coli host cell proteins, Biopharmaceuticals, Biopharmaceutical

研究领域

Education, Biological Sciences, Medicine

参考文献

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基金

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补充材料

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附加信息

利益冲突

No competing interests were disclosed.

数据可用性声明

The datasets generated during and / or analyzed during the current study are available from the corresponding author on reasonable request.

知识共享许可协议

Copyright © 2023 Jain. This is an open access work distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.