Journal of Vaccines & Vaccination

Immunoassays for unwanted and wanted immunogenicity including validation

6^th Euro Global Summit and Expo on Vaccines & Vaccination

August 17-19, 2015 Birmingham, UK

Melody Sauerborn

Keynote: J Vaccines Vaccin

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.

Biography :

Melody Sauerborn spent most of her undergrad years in well-known institutes such as the Centers for Disease Control and Prevention in Atlanta to widen her knowledge
in virology and immunology. After obtaining her PhD, where she investigated the immunological aspects of antibody formation against aggregated protein therapeutics, she
spent numerous years as a project leader, trainer and senior expert in immunogenicity and bioanalysis. Currently she is the head of non-clinical development at Mymetics,
a viral vaccine company based in the Netherlands.