Manufacture To Control: Considerations In CMC For Antibody-Drug Conjugates

Antibody-drug conjugates (ADCs) represent a sophisticated therapeutic modality that surpasses the complexity of traditional antibodies, necessitating meticulous attention to Chemistry, Manufacturing, and Controls (CMC). This presentation comprehensively explores the multifaceted considerations imperative for the successful manufacture and control of ADCs.

Following a concise overview of ADCs, we delve into critical aspects of ADC manufacturing, encompassing material management, stringent facility design requirements, and robust process control, all of which are indispensable for achieving high-quality production. Moreover, we address strategies for impurity control and other pivotal factors essential for preserving product integrity.

Gain valuable insights and practical guidance for navigating the intricate landscape of ADC CMC development, ensuring the delivery of safe and efficacious biopharmaceutical products.