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ISBN 9783843908177

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978-3-8439-0817-7, Reihe Pharmazeutische Technologie

Angelika Juliane Freitag
The Immunogenicity of Protein Aggregates: Studies on a Murine Monoclonal Antibody in Wild-Type Mice

191 Seiten, Dissertation Ludwig-Maximilians-Universität München (2012), Softcover, A5

Zusammenfassung / Abstract

The potential contribution of protein aggregates to the unwanted immunogenicity of protein pharmaceuticals is a major concern. In the present thesis a murine monoclonal antibody was utilized to study the immunogenicity of aggregates of a model therapeutic antibody in mice. Prior to the animal studies, a variety of aggregates were prepared by processes that are relevant in product manufacturing, such as stirring, shaking, exposure to UV light stress and exposure to elevated temperatures. The aggregates were well characterized by numerous physico-chemical techniques.

This study shows how the severity of an immune reaction depends on the nature of the aggregates, and that the versatile aggregates investigated in this study are not equally immunogenic in wild-type mice.