# High-Resolution Native Capillary Zone Electrophoresis with Inline UV and Native Mass Spectrometry for Characterizing Charge Variants in Biologics

> **NIH NIH R44** · GMJ TECHNOLOGIES, INC. · 2024 · $350,000

## Abstract

PRJECT SUMMARY
 Fast evolution of blockbuster biologics such as monoclonal antibodies, antibody drug conjugates,
fusion proteins, and gene therapy, is creating a strong demand for efficient analytical tools to characterize
and monitor product variants that could negatively impact safety and efficacy. During production in cell
culture, formulation, and storage, protein therapeutics can undergo post-translational modifications that
could lead to charge variants (CVs). CVs are product variants with a net charge different from that of the
intended product. The International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH) guidelines identify CVs as a critical quality attribute because of their
potential impact on the quality, safety, and efficacy of the product. Also, the U.S. Food and Drug
Administration guidance recommends a comprehensive characterization of CVs in regulatory submissions.
As a result, analytical monitoring of CVs is routine in product and process development, quality control
and lot release.
 In the biopharmaceutical industry (biopharma), there is a growing interest in characterizing CVs
with native mass spectrometry (MS) to ascertain the underlying post-translational modifications and
potentially correlate with biological functions. For CVs characterization at the intact protein level, efficient
separation is a critical step before MS detection to separate the variants, reduce sample complexity, and
allow the detection of low abundant species. The most widely used separation techniques for CVs analysis
in biopharma are (imaged) capillary isoelectric focusing and ion exchange chromatography but their
applications for CVs characterization in native state are limited due to either inadequate resolution or
incompatible separation conditions.
 GMJ Technologies (GMJ) is developing a high-resolution native capillary zone electrophoresis with
native mass spectrometry for CVs characterization. Our approach combines multiple innovative solutions
in capillary surface chemistry that produces high resolution of CVs by capillary zone electrophoresis, a
novel optical-electrospray interface that provides inline optical and native mass detections, and a sensitive
nanoflow electrospray mechanism that preserves proteins’ native conformation. With this innovation,
GMJ aims to address a gap in the characterization and quality control of protein therapeutics from
research to commercialization. By eliminating several laborious steps, the proposed technique will
significantly improve the efficiency in the characterization workflow for CVs, improve the analysis
precision and sensitivity, provide cost-saving benefits, and contribute to development and manufacturing
of novel biologics and protein-based medicines.

## Key facts

- **NIH application ID:** 11006980
- **Project number:** 1R44GM156142-01
- **Recipient organization:** GMJ TECHNOLOGIES, INC.
- **Principal Investigator:** Oluwatosin Dada
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $350,000
- **Award type:** 1
- **Project period:** 2024-08-01 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11006980

## Citation

> US National Institutes of Health, RePORTER application 11006980, High-Resolution Native Capillary Zone Electrophoresis with Inline UV and Native Mass Spectrometry for Characterizing Charge Variants in Biologics (1R44GM156142-01). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/11006980. Licensed CC0.

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