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

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Authors

Kalpesh Jain¹

1. COO

Conference / event

Immunocon, January 2009 (Virtual)

Poster summary

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.

Keywords

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

Research areas

Education, Biological Sciences, Medicine

References

No data provided

Funding

No data provided

Supplemental files

No data provided

Additional information

Competing interests

No competing interests were disclosed.

Data availability statement

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

Creative Commons license

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.