Control Strategies for Antibody-Drug Conjugates Drug Product Manufacturing

Antibody-drug conjugates (ADCs) have unique attributes that pose challenges in the development and manufacturing. A control strategy for ADC drug product (DP)-related critical quality attributes (CQA) was developed based on the assessment of product quality attribute criticality and process capability. Appropriate and multiple levels of control assure these quality attributes can be consistently maintained by the DP manufacturing process..