The presentation will focus on studies needed for clinical supplies and for commercial readiness with the goal of providing evidence of process consistency. Case studies will be presented as well as basic process engineering understanding of equipment and chemistry. The discussion will focus on the use of
automated systems for gathering information for early phase process transfers to manufacturing to provide guidance on unit operations. The second part of the talk will be on DOEs that ensure appropriate ranges are evaluated and ensure deep process understanding.
Speakers: Lisa McDermott, Principal Scientist, Process and Analytical Development
Visit us at Booth # 23
Stop by our booth to speak with our experts about latest advances in single-use processing or to solve the challenges of your ADC program from gene sequence to testing of drug product.
Meeting details and registration : https://worldadc-usa.com/