This article describes the current situation in FDA-regulated areas, as well as characterization of these products. Finally,the author discusses the various stages of early- and late-phase product developments.
Characterization of Product Related Variants in Therapeutic Monoclonal Antibodies
July 16th 2024Navin Rauniyar and Xuemei Han of Tanvex Biopharma USA recently discussed how identifying product-related variants through characterization enables the recognition of impurities that compromise the quality and safety of drugs.