Formulation and Quality – Biomolecular
This presentation focusses on the complex protein degradation chemistry observed under conditions of accelerated stability and stress testing. Experiments are conducted in order to correlate chemical protein modifications with immunogenicity. The experimental design of such studies, and potential pitfalls of the experimental design, will be discussed. In animal experiments, immunogenicity can be associated with certain peptide fractions obtained from a monoclonal antibody. However, our data suggest that protein modifications may cause immunogenicity by more than one mechanism.