AI Implementation Masterclass

About this event

The manufacturing of Antibody-Drug Conjugates (ADCs) is intrinsically complex, and a robust Chemistry, Manufacturing, and Control (CMC) strategy is vital due to the complex nature of these therapeutics and the history of failures at both early and late stages.

This training encompasses a comprehensive understanding of the primary technical and regulatory challenges (FDA and EMA), focusing on the specific requirements for ADCs. ADCs combine the targeting capabilities of antibodies with the cell-killing or effector capabilities of payload drugs. The overall operational excellence and Quality approach are highlighted, along with critical control points to ensure the consistency, purity, and stability of ADCs, given their high potency and specific targeting mechanisms. The training also covers good manufacturing practices (GMP) procedures, especially tech transfer, documentation, and facility controls, which are crucial for minimizing cross-contamination risks. This training combines theoretical knowledge with workshopping for a deeper understanding, preparing professionals for the unique challenges in ADC manufacturing.