Sandra Prior

Company: Medicines and Healthcare Products Regulatory Agency

Job title: Senior Scientist

Seminars:

Supporting Global Harmonisation & Traceability of Biotherapeutic Monoclonal Antibodies’ Fc-Mediated Functions: the Role of WHO International Standards & Reference Reagents 3:00 pm

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…Read more

day: Conference Day Two