Establishing Patient-centric Quality Standards: Monoclonal Antibody Case Studies

ICH Q8 (R2) allows for the use of alternative approaches for establishment of specifications compared to that outlined in ICH Q6, based on the level of relevant scientific knowledge that is provided to support and justify the approach. The presentation will describe and provide case studies to outline how attribute risk assessments, coupled with product specific and relevant prior knowledge, can be used to establish a patient-centric control strategy. By focusing on attribute criticality and risk, patient centric approaches allow flexibility for attributes with a low risk of impacting clinical performance, while ensuring appropriate control for attributes with a higher risk of impacting safety and/or efficacy.