Biologics Analysis Workflow™ Model Comparability Study for Changes to Validated cGMP SDS-PAGE Assays with the GS-900™ Calibrated Densitometer

This report presents a model comparability study for the evaluation of SDS-polyacrylamide gel electrophoresis (SDS-PAGE) assays using calibrated densitometry. SDS-PAGE and calibrated densitometry are standard techniques used to resolve and quantitate proteins for purity/impurity analysis. Bio-Rad has developed the Biologics Analysis Workflow specifically for GMP labs evaluating the composition of biologics with SDS-PAGE and calibrated densitometry. The workflow and each of the steps it comprises deliver ease of use, reproducibility, and accuracy.