- Patent Title: Methods of fingerprinting therapeutic proteins via a two-dimensional (2D) nuclear magnetic resonance technique at natural abundance for formulated biopharmaceutical products
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Application No.: US17442891Application Date: 2020-03-26
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Publication No.: US12078701B2Publication Date: 2024-09-03
- Inventor: Tsang-Lin Hwang , Mats H. Wikstroem
- Applicant: AMGEN INC.
- Applicant Address: US CA Thousand Oaks
- Assignee: Amgen Inc.
- Current Assignee: Amgen Inc.
- Current Assignee Address: US CA Thousand Oaks
- Agent Melissa E. Karabinis
- International Application: PCT/US2020/025078 2020.03.26
- International Announcement: WO2020/198538A 2020.10.01
- Date entered country: 2021-09-24
- Main IPC: G01R33/46
- IPC: G01R33/46 ; G01R33/465

Abstract:
Methods of fingerprinting a specific molecule in a composition using nuclear magnetic resonance (NMR) is disclosed. The disclosed NMR methods provide several modifications and improvements over existing NMR techniques. In some embodiments, the methods include applying a cycle of signal processing steps, including applying a radio frequency (RF) pulse, applying a gradient pulse having a pulse length less than or equal to 1000 μs, and applying a water suppression technique (WET). In some embodiments, the methods further include repeating the cycle for at least 3 times to acquire an enhanced signal of the composition. In some embodiments, the methods further include fingerprinting the specific molecule based on the enhanced signal of the composition.
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