Implementation of the EU Directive proves to be challenging as regulatory variations among member states continue and questions remain unanswered.
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.