Automated, GMP-compliant HIV ImmunoPET tracer production for broader clinical use
Official title: Improving availability of ImmunoPET via automation of radio-synthesis and quality control of antibody-based HIV imaging PET tracers on a single platform.
Funded at Trace-Ability, INC. · NIH-11300991 · Data updated 2026-11-12
A new automated system will make HIV-imaging tracers quickly and safely in more clinics, so more people could benefit from ImmunoPET scans.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Trace-Ability, INC. NIH-funded |
| Lab location | 1 site (Van Nuys, United States) |
| Project start | January 15, 2024 |
| Project end | December 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $1,000,000 |
| NIH project number | 5R44AI162202-04 |
| Project ID | NIH-11300991 on NIH RePORTER |
Who could benefit from this research
✓Could help
People living with HIV who may benefit from ImmunoPET imaging to visualize disease processes or monitor response to therapy.
✕Less likely to help
Patients without access to PET imaging or those not undergoing HIV ImmunoPET studies may not benefit directly.
What this research studies
This project aims to create Tracer-ONE, a compact automation platform that handles the full production and quality control of Zirconium-89 labeled HIV antibodies for PET imaging. It builds on prior work to enable easy kit-based operation, requiring minimal staff training, and delivers labeling, QC results, and a ready-to-use product before the scan. The system is designed to be scalable, GMP-compliant, and usable in centers with limited resources, expanding access to ImmunoPET for HIV patients. Phase II will finalize a fully functional setup suitable for clinical production of multiple ImmunoPET tracers. The HIV-focused application is chosen to maximize immediate patient impact in imaging-guided care and trial participation.
Why it matters
Potential benefit: If successful, this platform could democratize access to ImmunoPET imaging for HIV, potentially guiding treatment decisions and accelerating HIV-related clinical trials.
How similar studies have gone: Previous Phase I work showed key capabilities; Phase II aims to deliver a complete, clinically deployable system.
Where this research is happening
-
Trace-Ability, INC.
Van Nuys, United States Active
Researchers
- Principal investigator: Elizarov, Arkadij — Trace-Ability, INC.
- Study coordinator: Elizarov, Arkadij
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.