Biologics and Biosimilars
Monoclonal antibody aggregation can arise from multiple mechanisms, including product and environmental factors. Size exclusion chromatography (SEC) is a standard method to determine and quantify aggregation and fragment levels of monoclonal based therapeutics. The focus of this application note is to showcase high-resolution separation and quantification of intact, aggregates, and fragments of biosimilar and innovator rituximab obtained from forced-stress studies. Separation and quantification was achieved using an Agilent 1260 Infinity Quaternary Bio-inert LC and an Agilent AdvanceBio SEC column. Calibration of the column was performed using molecular weight markers. The AdvanceBio SEC column provided sensitive and high-resolution separation for monitoring aggregates/degradants, and is ideal for applications where high resolution and sensitivity are essential.
Publication number: 5991-6304EN
Publication Date: October 16, 2015