Method Modernization for Routine Analysis of Biotherapeutics as Part of Lifecycle Management

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Ximo Zhang, Robert Birdsall, and Ying Qing Yu
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This work demonstrates the modernization of the USP monograph for high-throughput identity test of insulin analogues.

Using a sub-2-μm particle size column and ion-pairing reagent TFA, the HPLC-based USP method was updated to an UPLC-based method with higher efficiency for the separation of digested peptides of insulin analogues. Compared to original USP methods, the developed method reduced analysis time by 75% with comparable resolution and can be applied to multiple insulin analogues, making it an ideal platform method for insulin analysis in a routine environment.

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