Melody Sauerborn
Head of non clinical development at Mymetics BV
Title: Immunoassays for wanted and unwanted immunogencity including validation
Biography
Biography: Melody Sauerborn
Abstract
Bioanalytical assays are a pivotal part of drug development, whether it is for determining and measuring the correlate of protection or the safety and efficacy of a drug product. This workshop will focus on ligand binding and cell based assays from scratch to fully validated assays as used for vaccines and biologicals. The first part will cover how to set up an assay, what parameters are important to test and control, such as blocking reagents, edge effect and many more. The second part will give an overview about the current bioanalytical guidelines on assay validation as issued by regulatory authorities and how we can implement them. Finally, we will look at the current discussion about qualification versus validation of bioanalytical assays. At the end of the workshop, the participants should have a broad overview about bioanalytical assay set up and validation and what the current requirements are.