Introduction
De-risk your synthetic peptide drug products with PI Health Sciences’ comprehensive immunogenicity risk assessment platform. We use advanced in vitro immunogenicity assays with human primary cells to evaluate both innate and adaptive immune responses, helping you identify and mitigate immunogenicity concerns early in development.
Our platforms include:
- Innate Immunity: A 25-donor study assessing viability and cytokine responses to potential Innate Immune Response Modulating Impurities (IIRMS).
- Adaptive Immunity: A 30-donor study, representing a majority of haplotypes, to evaluate naïve T-cell responses and MHC Class II binding.
- In Silico Prediction: Full risk prioritization including epitope mapping and HLA binding prediction.
Our services follow FDA immunogenicity guidance and are conducted under GLP-like conditions to ensure high-quality, regulatory-ready outputs.
Fill out the form to download the full brochure and learn how our immunogenicity risk assessment services support safer, more predictable peptide drug development.
