Lang-Shan Jiang

Critical Quality Attributes and Manufacturing Process Control Strategies of Antibody–Drug Conjugates: A QbD /Risk Assessment Perspective

Antibody–drug conjugates (ADCs) have emerged as an important class of targeted cancer therapeutics by combining the specificity of monoclonal antibodies with the potency of cytotoxic payloads. Their complex molecular structure and multi-step manufacturing process, however, there are significant challenges for product c...