Accelerated development of a SEC-HPLC procedure for purity analysis of monoclonal antibodies using design of experiments
Terezie Cernosek, Nitin Jain, Matthew D. Dalphin, Sue Behrens, Peter Wunderli
Topics & Concepts
Critical quality attributesBiopharmaceuticalMonoclonal antibodyChemistrySize-exclusion chromatographyChromatographyResolution (logic)Quality by DesignProcess engineeringBiochemical engineeringComputer scienceAntibodyBiotechnologyBiologyParticle sizeBiochemistryPhysical chemistryEnzymeEngineeringArtificial intelligenceImmunologyProtein purification and stabilityMonoclonal and Polyclonal Antibodies ResearchAnalytical Chemistry and Chromatography