Risultati finali
We developed and partly validated an in vivo predictive model for the immunogenicity of hIFNá2a in patients. It is based on a transgenic mouse model that is immune tolerant for hIFN 2. The mice were made immune tolerant by introducing the gene code for the rhIFNá2 into the chromosomal DNA of the mice. A sensitive ELISA was developed to measure rhIFN2-specific antibody levels.
We used this model to study relationships between rhIFN2 structure and immunogenicity. Protein structure was varied by means of preparing well-defined degradation methods. The results indicate that our immune-tolerant animal model may be useful to screen rhIFN2 formulations or structural variants for their immunogenicity before they are tested in clinical trials.
Apart from pharmaceutical scientists also immunologists might be interested in the model, since it will be useful to study the mechanism of breaking of immune tolerance and also to evaluate treatments for patients who developed high levels of neutralizing antibodies.
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