Patents
Automated real-time, on-line n-glycosylation monitoring methods and systems thereof
U.S. Patent Application (No. 18/375,243) | Published: April 4, 2024
This patent application describes an innovative method and system for real-time, automated monitoring of N-glycosylation during the continuous biomanufacturing of biologics, such as monoclonal antibodies. The invention combines sequential injection analysis (SIA) with liquid chromatography and employs a rapid, sensitive labeling chemistry for instant N-glycosylation analysis. The system integrates various components, including a bioreactor, protein A column, UV spectrometer, and specialized valves and pumps, to enable continuous sampling, protein purification, deglycosylation, and glycan labeling. The method utilizes a fluorescent labeling reagent called Instant PC (IPC) for sensitive detection of glycans. This approach aims to improve the efficiency and quality control of biologic production by shifting from traditional batch processes to continuous manufacturing, while providing real-time monitoring of critical quality attributes like N-glycosylation.
Recommended citation: Gyorgypal, A., & Chundawat, S. P. (2024). "Automated real-time, on-line n-glycosylation monitoring methods and systems thereof." U.S. Patent Application No. 18/375,243.