Charge Variants Characterization of Co-Formulated Antibodies by Three-Dimensional Liquid Chromatography-Mass
Xiaoqing Jin1, Luna Chen1, Jianlin Chu2
1College of Biotechnology and Pharmaceutical Engineering, Nanjing Tech University, Nanjing 211816, China.
Biomolecules
|August 29, 2024
Summary
A new three-dimensional liquid chromatography-mass spectrometry (3D-LC-MS) method effectively characterizes charge variants in co-formulated antibodies. This technique provides crucial data for quality control and stability studies of these complex biologics.
Area of Science:
- Biopharmaceutical Analysis
- Analytical Chemistry
- Chromatography
Background:
- Co-formulated antibodies offer clinical advantages but pose analytical challenges.
- Accurate quality analysis of multiple antibodies in one solution is difficult.
- Existing methods struggle to separate charge variants of similar co-formulated antibodies.
Purpose of the Study:
- To develop a novel method for characterizing charge variants in co-formulated antibodies.
- To enable simultaneous analysis of charge variants ratio and post-translational modifications.
- To address limitations in current quality control and stability testing approaches.
Main Methods:
- Utilized three-dimensional liquid chromatography-mass spectrometry (3D-LC-MS).
- Employed hydrophobic interaction chromatography (HIC) for initial antibody separation.
- Applied ion exchange chromatography (IEC) for charge variant separation and reverse-phase chromatography (RPC) for desalting and mass spectrometry.
Main Results:
- Successfully separated and analyzed charge variants of two co-formulated antibodies.
- Provided simultaneous charge variants ratio and post-translational modification (PTM) data.
- Demonstrated the method's capability for comprehensive characterization.
Conclusions:
- The novel 3D-LC-MS method offers a robust solution for co-formulated antibody analysis.
- This approach is suitable for release testing and stability studies.
- Represents a significant advancement in the characterization of co-formulated antibody charge variants.
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