Quantitation and speciation of residual protein within active pharmaceutical ingredients using image analysis with SDS-PAGE

Joseph P Smith,Nicole M Ralbovsky,Mackenzie L Lauro,Erik Hoyt,Erik D Guetschow,Fengqiang Wang,John A McIntosh,Zhijian Liu,Ian Mangion,Narayan Variankaval,Xiaodong Bu

Journal of Pharmaceutical and Biomedical Analysis（2022）

引用 6|浏览22

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摘要

•Quantitation of residual protein within an API is critical for a robust drug product.•Total residual protein within an API was quantitated using SDS-PAGE image analysis.•Speciation of residual protein was accomplished for improved API purification.•Results were in good agreement compared to traditional ELISA methodology.•The method has broad applicability across biocatalytic process development efforts.

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关键词

Biocatalysis,Directed enzyme evolution,Process research & development,Pharmaceuticals,Densitometry,Electrophoresis

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