Analyzing charge variants in biologic drugs using advanced techniques
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-11142793 · Data updated 2026-11-12
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.
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 | 2025 |
| Award (this year) | $1,597,901 |
| NIH project number | 4R44GM156142-02 |
| Project ID | NIH-11142793 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for benefiting from this research include patients receiving biologic therapies for conditions such as cancer or autoimmune diseases.
✕Less likely to help
Patients who are not receiving biologic therapies or those with conditions unrelated to the use of biologics may not benefit from this research.
What this research studies
This research focuses on developing a high-resolution analytical tool to identify and characterize charge variants in biologic drugs, such as monoclonal antibodies and antibody-drug conjugates. By utilizing native capillary zone electrophoresis combined with inline UV and mass spectrometry, the project aims to improve the monitoring of product variants that may affect the safety and efficacy of these therapeutics. The methodology involves separating different charge variants to better understand their properties and potential impacts on patient treatment outcomes.
Why it matters
Potential benefit: If successful, this research could enhance the safety and effectiveness of biologic therapies by ensuring that only the highest quality products are used in patient treatments.
How similar studies have gone: Other research has shown success in using advanced analytical techniques to characterize biologics, indicating that this approach is promising and builds on established methodologies.
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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High-Resolution Tool to Characterize Charge Variants in Biologics
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.
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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.