Assessing the risk of immune reactions to protein impurities in biologic drugs
Official title: Validation and Improvement of ISPRI-HCP: An Innovative Platform for Immunogenicity Risk Assessment of Process-related Protein Impurities
Funded at Epivax, INC. · NIH-10603538 · Data updated 2026-11-12
This study is looking at how certain tiny impurities in biologic drugs and vaccines might cause immune reactions, with the goal of making these treatments safer and more effective for patients.
Quick facts
| Grant type | Sbir 1 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Epivax, INC. NIH-funded |
| Lab location | 1 site (Providence, United States) |
| Project start | August 1, 2023 |
| Project end | July 31, 2025 |
| Funding year | 2023 |
| Award (this year) | $299,917 |
| NIH project number | 1R43AI174486-01 |
| Project ID | NIH-10603538 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are individuals receiving biologic therapies or vaccines that may contain protein impurities.
✕Less likely to help
Patients who are not receiving biologic drugs or vaccines may not benefit from this research.
What this research studies
This research focuses on improving the safety of biologic drugs by evaluating the risk of immune reactions caused by protein impurities. Using an innovative platform called ISPRI-HCP, the study will analyze specific protein impurities found in biologics and vaccines, particularly those derived from Chinese Hamster Ovary cells and adenoviral vaccines. The approach involves testing T cell responses to these impurities to better predict their immunogenicity risk. By identifying and classifying these risks, the research aims to enhance drug safety and efficacy for patients.
Why it matters
Potential benefit: If successful, this research could lead to safer biologic drugs with reduced risk of immune reactions for patients.
How similar studies have gone: Previous research has shown promise in using similar immunogenicity assessment approaches, indicating potential for success in this novel application.
Where this research is happening
-
Epivax, INC.
Providence, United States Active
Researchers
- Principal investigator: Haltaufderhyde, Kirk Donald — Epivax, INC.
- Study coordinator: Haltaufderhyde, Kirk Donald
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.