Analysis of mAb Aggregates by Nexera™Bio UHPLC with a Shim-pack™Bio Diol (Size Exclusion) Column

Introduction

Monoclonal antibodies (mAb) are important biologics for the treatment of cancers. The production of mAb biosimilar is challenging, because various variations may occur in upstream and downstream processing (DSP). Protein aggregation is one of such variations ─ a biological phenomenon in which mAb accumulate and clump together. Aggregation is a critical quality attributes (CQAs), as the aggregates not only reduce the efficacy of mAb biosimilar drug, but also can stimulate immunogenic responses, leading to various adverse events in treatment. Thus, the accurate analysis of monomer, dimer, and higher aggregates of mAb is required for developing higher quality therapeutics. We present here a robust, well- established size exclusion chromatography (SEC) approach for mAb aggregate analysis.

September 13, 2019 GMT