(609c) Process Development and Scale-up of ADC Conjugation Processes

Antibody-drug conjugates (ADCs) are a class of pharmaceuticals that use an antibody to selectively deliver a cytotoxic drug to cancer cells. Process development for the purification of these modalities via Tangential Flow Filtration (TFF) typically requires screening of several conditions at gram scales to develop robust processes. Via the establishment and use of platform methods and high-throughput screenings, the development of these processes can be accelerated, enabling rapid scale-up while maintaining key product quality attributes. Modeling of both total and individual impurity removal enables deep understanding of the TFF process and is scalable from the lab to the plant. This presentation will highlight these methodologies to enable strategic process development for ADC purification via TFF. Model studies will be presented where the approach was successfully used for process development and subsequent scale-up for non-clinical deliveries.