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Managing Immunogenicity Risk through Assay-based Rational Drug Design and Selection

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The document addresses issues including how to manage immunogenicity effectively, improvement of drugs through better rational design methods, and what can be learned from measuring T cell responses at the preclinical stage.

Immunogenicity is the second most critical factor in the success of biologics, after mode of action, and is also the most complex of the bio-analytical challenges faced in drug design and development. This paper follows ProImmune’s conference ‘Mastering Immunogenicity’, held in September this year, which saw key opinion leaders in the immunogenicity field come together for a two day summit to define successful strategies for managing immunogenicity risk.