High-Resolution Tool to Characterize Charge Variants in Biologics
Official title: High-Resolution Native Capillary Zone Electrophoresis with Inline UV and Native Mass Spectrometry for Characterizing Charge Variants in Biologics
Funded at Gmj Technologies, INC. · NIH-11325751 · Data updated 2026-11-12
A new NIH-funded project aims to develop a high-resolution method to separate and identify charge variants in biologic medicines to help ensure their safety and effectiveness.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Gmj Technologies, INC. NIH-funded |
| Lab location | 1 site (Everett, United States) |
| Project start | August 1, 2024 |
| Project end | February 28, 2027 |
| Funding year | 2026 |
| Award (this year) | $902,099 |
| NIH project number | 5R44GM156142-03 |
| Project ID | NIH-11325751 on NIH RePORTER |
Who could benefit from this research
✓Could help
Not applicable to direct patient enrollment; the study involves analytical development using biologic products and samples.
✕Less likely to help
No direct patient participation or recruitment is involved in this grant.
What this research studies
This project focuses on improving how we analyze complex biologic drugs like antibodies and conjugates by using capillary electrophoresis linked with inline UV and native mass spectrometry. The goal is to accurately separate variant forms that differ in charge, which can affect a product’s safety and efficacy. The research will optimize a workflow that goes from separation to mass analysis, enabling clearer understanding of how post-translational changes arise during production and storage. By providing detailed variant profiles, this work could streamline regulatory-quality characterization and support better quality control in biopharma.
Why it matters
Potential benefit: If successful, patients could benefit from more consistent and safer biologic medicines due to improved detection and characterization of problematic variants.
How similar studies have gone: Similar approaches using native MS and CE have shown promise in resolving charge variants in complex biologics, with ongoing demonstrations of improved characterization.
Where this research is happening
-
Gmj Technologies, INC.
Everett, United States Active
Researchers
- Principal investigator: Dada, Oluwatosin — Gmj Technologies, INC.
- Study coordinator: Dada, Oluwatosin
Related research
Other NIH-funded projects on the same topics.
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Analyzing charge variants in biologic drugs using advanced techniques
This study is working on a new tool to help scientists better understand different forms of biologic drugs, like monoclonal antibodies, to ensure they are safe and effective for patients.
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Improving the analysis of monoclonal antibodies to ensure their safety and effectiveness
This study is working on improving the way we check monoclonal antibodies, which are important medicines for treating various health issues, to make sure they are safe and effective by finding and fixing any impurities that might show up during their production.
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.