ADC is one of the fastest growing modality of oncology drugs. The molecules are complex and require improved understanding of critical quality attributes to ensure efficacy, safety and stability of the product. As the number of approved ADC increases, regulatory expectations have also evolved. This presentation will focus on the understanding of critical quality attributes and the control strategy from a regulatory perspective.
Learning Objectives:
Upon completion, the audience will appreciate the complexity and challenges associated with complex biologics, such as ADC.
Upon completion, the audience will learn the importance of regulatory science in setting the frame-work for novel product development
Upon completion, the audience will learn the importance of early interaction between technical and regulatory CMC.
