Discussion

Pharmacokinetic studies are important in clinical trials to investigate the PK/PD relationships. LFB BT has developed a fully human recombinant monoclonal antibody, Roledumab. This anti-Rh(D) antibody has been developed for the prevention of Rh(D) alloimmunisation. A clinical phase IIb study is ongoing, primary endpoint will be assessment of pharmacokinetic profile. Roledumab is injected twice to women, first during the 28th week of pregnancy then between delivery and 72 hours post-delivery. In order to define Roledumab pharmacokinetic profile, we have quantified Roledumab in human serum (according to method described in the EMA and FDA guidelines on bioanalytical method validation). Rh(D) antigen being a conformational antigen, a flow cytometry method has been developed and validated. This talk will discuss and present the flow cytometry methodology applied as well as results from method validation. Flow cytometry will be presented as an appropriate method for high throughput testing and to measure, in an accurate manner and in human serum, an antibody directed against a conformational epitope.