Affiliation:
1. National Institutes for Food and Drug Control State Key Laboratory of Drug Regulatory Science NHC Key Laboratory of Research on Quality and Standardization of Biotech Products NMPA Key Laboratory for Quality Research and Evaluation of Biological Products Beijing P. R. China
Abstract
AbstractAn imaged capillary isoelectric focusing (icIEF)‐based method was developed and validated as a multi‐attribute method for a bispecific antibody (BsAb). First, as the traditional application of the icIEF method, it serves as an identity assay and purity assay for the BsAb. Second, the method can also be used as an impurity assay for the homodimer monoclonal antibodies generated during BsAb assembly. The homodimer impurity analysis for BsAb is usually done by hydrophobic interaction chromatography methods in the industry. The icIEF method has good sensitivity (down to 4 µg/mL in a limit of quantitation) when UV fluorescence detection is used, which detects the native fluorescence of proteins. This is the first report that an icIEF method has been applied as impurity assay.
Funder
National Key Research and Development Program of China