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The use of transgenic animals to predict immunogenicity of new biologics is increasing. In recent years transgenic animals
immune tolerant for the protein drug of interest have proven useful tools to investigate the immunogenic potential of protein
drugs and factors influencing immunogenicity. This presentation will introduce the basics of transgenic animals and their use in
immunogenicity testing. We will show data from transgenic mouse models immune tolerant for human interferon alpha and beta
and how we compared different human interferon alpha and beta products in terms of immunogenicity.
These models are very sensitive to formulation issues (e.g. aggregation), and introduction of neo-epitopes and a very useful
tools to perform comparative studies of biosimilars. With the upsurge of well-defined transgenic animal models, biosimilars can
also benefit from these models.
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 immunology. After acquiring her Masters in Science she joined the lab of Prof. Schellekens and Prof. Jiskoot, two experts in
immunogenicity of protein drugs, to shed more light on the immunological aspects of antibody formation against aggregated protein therapeutics.
After obtaining her PhD she started a spin-off, ADA InVivo BV, a biotech CRO in the field of drug safety. Currently she is a project leader at the
bioanalysis and immunogenicity department at TNO Triskelion BV, a Dutch CRO.
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