De-Risking Preclinical Candidates With Predictive Immunotoxicology

Assessing the immunotoxicology potential of candidate therapeutics is a complex process that lacks standardized regulatory guidance. Rather, it falls to the drug developer to propose and perform a suitable suite of assessments that can be used to understand the risk posed by a given therapeutic. For many organizations, this requirement presents challenges in delivering an appropriate set of assessments for regulatory review.

Even small molecule drugs and biologics that do not aim to modulate the immune system may incite immunotoxicity. A strategic approach employs predictive immunotoxicology assays all throughout development; used early in the discovery phases, this data can improve lead selection and mitigate the risk of costly late-stage failures; as part of a robust IND package, this data provides regulatory authorities with a clear understanding of your therapy’s safety profile.

Mitigate risk with early, actionable immunology data. Immunological processes play a role in most cell interactions and diseases across all systems. From target engagement and mechanism of action to efficacy and prediction of adverse immune reactions, immunology assays deliver data that reduce your risk of failing later.