Immunogenicity Risk Assessment of mRNA Therapeutics - Key Considerations When Assessing Preclinical Immunogenicity Risk

This poster highlights Lonza’s approach to preclinical immunogenicity risk assessment for mRNA/LNP therapeutics using human in vitro assays. Immunogenicity is influenced by multiple product‑ and process‑related factors, many of which can be evaluated early using well‑characterized human PBMCs. High‑quality cryopreserved PBMCs enable sensitive and robust assessment of innate immune activation, supporting potency assessment, lead selection, and safety evaluation. PBMC activation assays can differentiate immune responses driven by mRNA design and LNP formulation, with cytokine profiling providing clinically relevant insight. These human‑cell–based tools help optimize mRNA potency while minimizing unwanted immunogenicity before clinical development.