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Updated: Aug 24, 2026

Highly Sensitive and Quantitative Detection of Proteins and Their Isoforms by Capillary Isoelectric Focusing Method
Published on: September 19, 2018
Capillary electrophoresis of proteins in a quality control environment
David L Good1, Stacey Cummins-Bitz, Raeann M Fields
1Indianapolis Bulk Operations Technical Excellence Centre, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN., USA.
Abstract:
A method for determining the purity of recombinant carboxypeptidase B utilizing CE-SDS has been developed and validated for use in a manufacturing quality control laboratory. The method was optimized, prior to validation, to allow for the lowest limit of quantitation. The method was validated with the typical ICHQ2A parameters, including accuracy, linearity, LOQ, precision, robustness/ruggedness, and specificity. All validation parameters met the acceptance criteria defined in the validation protocol.
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