Applying UHPLC-HRAM MS/MS Method to Assess Host Cell Protein Clearance during the Purification Process Development of Therapeutic mAbs
Abstract
:1. Introduction
2. Results
2.1. Development of a Sensitive and Robust UHPLC MS/MS Method for HCP Monitroing
2.1.1. Workflow of the Developed UHPLC MS/MS Method
2.1.2. Increasing HCP Identification Coverage by Using Multiple Database Research Algorithms
2.2. Evaluating the Performance of the Developed UHPLC MS/MS Method for HCP Analysis
2.3. Applying the Developed UHPLC MS-MS/MS Method for HCP Profiling in Purification Process of Therapeutic Proteins
3. Discussion
4. Materials and Methods
4.1. Materials
4.2. Sample Preparation
4.3. HPLC MS/MS Analysis
4.4. Data Processing
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Kiyonami, R.; Melani, R.; Chen, Y.; Leon, A.D.; Du, M. Applying UHPLC-HRAM MS/MS Method to Assess Host Cell Protein Clearance during the Purification Process Development of Therapeutic mAbs. Int. J. Mol. Sci. 2024, 25, 9687. https://doi.org/10.3390/ijms25179687
Kiyonami R, Melani R, Chen Y, Leon AD, Du M. Applying UHPLC-HRAM MS/MS Method to Assess Host Cell Protein Clearance during the Purification Process Development of Therapeutic mAbs. International Journal of Molecular Sciences. 2024; 25(17):9687. https://doi.org/10.3390/ijms25179687
Chicago/Turabian StyleKiyonami, Reiko, Rafael Melani, Ying Chen, AI De Leon, and Min Du. 2024. "Applying UHPLC-HRAM MS/MS Method to Assess Host Cell Protein Clearance during the Purification Process Development of Therapeutic mAbs" International Journal of Molecular Sciences 25, no. 17: 9687. https://doi.org/10.3390/ijms25179687