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Protein Aggregation and Immunogenicity

Protein Aggregation and Immunogenicity

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Tools to predict immunogenicity<br />

• Process / formulation characterization<br />

(including aggregates, particles…)<br />

• Animal studies - transgenics<br />

• In silico B-cell prediction<br />

• In silico T-cell prediction<br />

• T-cell epitope screening assays<br />

• T-cell activation assays<br />

THE MAIN CHALLENGE NOW:<br />

• Clinical How studies to bridge the gap<br />

• Postmarketing surveillance / pharmacovigilance

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