Amgen Inc.
METHODS OF FINGERPRINTING THERAPEUTIC PROTEINS VIA A TWO-DIMENSIONAL (2D) NUCLEAR MAGNETIC RESONANCE TECHNIQUE AT NATURAL ABUNDANCE FOR FORMULATED BIOPHARMACEUTICAL PRODUCTS

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 .mu.s, 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