Co-Authored Journal Publication on MAPPS Assay with FDA

Title: The MHC Associated Peptide Proteomics Assay is a Useful Tool for the Non-Clinical Assessment of Immunogenicity

The propensity of therapeutic proteins to elicit an immune response poses a significant challenge in clinical development and safety of the patients. Assessment of immunogenicity is crucial to predict potential adverse events and design safer biologics.

In this recent study co-authored with the FDA, we employed MHC Associated Peptide Proteomics (MAPPS) to comprehensively evaluate the immunogenic potential of re-engineered variants of immunogenic FVIIa analog (Vatreptacog Alfa). Our finding revealed the correlation between the protein sequence affinity for MHCII and the number of peptides identified in a MAPPS assay and this further correlates with the reduced T-cell responses. Moreover, MAPPS enable the identification of “relevant” T cell epitopes and may contribute to the development of biologics with lower immunogenic potential.

Abzena’s authors include our Chief Scientific Officer, Dr Campbell Bunce, and Director of Immunology, Dr Edward Cloake.

Citation: Jankowski W, Kidchob C, Bunce C, Cloake E, Resende R and Sauna ZE (2023) The MHC Associated Peptide Proteomics assay is a useful tool for the non-clinical assessment of immunogenicity. Front. Immunol. 14:1271120. doi: 0.3389/fimmu.2023.1271120

Abzena’s Expertise in Immunogenicity

At Abzena, we have over 20 years of experience in developing phase-appropriate assays for the assessment of potency, efficacy, and safety.  Our unique EpiScreen® 2.0 platform assesses immunogenicity via flow cytometry and completely avoids radioactive assays, delivering better, more granular candidate selection data.

Disover our immunogenicity assay capabilities.

Download the journal publication by clicking below.

Download Publication