Rapid identification of antibody impurities in size-based electrophoresis via CZE-MS generated spectral library

Autor: Quan Liu, Jiaying Hong, Yukun Zhang, Qiuyue Wang, Qiangwei Xia, Michael D. Knierman, Jim Lau, Caleen Dayaratna, Benjamin Negron, Hirsh Nanda, Harsha P. Gunawardena
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Scientific Reports, Vol 14, Iss 1, Pp 1-13 (2024)
Druh dokumentu: article
ISSN: 2045-2322
DOI: 10.1038/s41598-024-70914-5
Popis: Abstract Methods for the reliable and effective detection and identification of impurities are crucial to ensure the quality and safety of biopharmaceutical products. Technical limitations constrain the accurate identification of individual impurity peaks by size-based electrophoresis separations followed by mass spectrometry. This study presents a size-based electrophoretic method for detecting and identifying impurity peaks in antibody production. A hydrogen sulfide-accelerated degradation method was employed to generate known degradation products observed in bioreactors that forms the basis for size calibration. LabChip GXII channel electrophoresis enabled the rapid (
Databáze: Directory of Open Access Journals
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