Supporting Global Harmonisation & Traceability of Biotherapeutic Monoclonal Antibodies’ Fc-Mediated Functions: the Role of WHO International Standards & Reference Reagents

Time: 3:30 pm
day: Conference Day Two

Details:

• Characterisation of biological activity is essential for regulatory approval and throughout the lifecycle of biotherapeutic monoclonal antibodies (mAbs). However, harmonisation and traceability of bioactivity data depend on the availability of public reference standards
• Complex mechanisms of action including Fc-domain mediated activities contribute to their clinical therapeutic and safety profile. International standards have a unique role in supporting the evaluation of potential bioactivity drifts for their various biological activities, longitudinally, and where different versions of a product exist
• New programme proposes the development of a WHO reference reagents panel as a global benchmark to support the development, performance and qualification of assays to investigate Fc-domain interactions