A surge in the development and commercialization of monoclonal antibody (mAb)-based therapeutics has driven the requirement for accurate and reproducible analytical methods for protein characterization. Monoclonal antibodies are popular biologic drug candidates, but are susceptible to a myriad of modifi cations during manufacture and complex degradation pathways during purifi cation and storage, often leading to distinct charge variants that require characterization and quantifi cation. Ion-exchange liquid chromatography (IEX) is a well-accepted and widely used technique to separate various mAb charge variant species for the sake of characterization and profi ling. With the most recent advances in analytical technologies, IEX can be used to help ensure the selection of stable and effi cacious mAb drug candidates, from discovery through manufacturing.
|TheColumn_Innovations in IEX for mAb Variant Analysis||3110.93kB|