A nondestructive and noninvasive method to determine water content in lyophilized proteins using low‐field time‐domain NMR

Determining the moisture content in lyophilized solids is a fundamental step towards predicting the quality and stability of lyophilized products, but conventional methods are time‐consuming, invasive, and destructive. High levels of residual moisture in a lyophilized product can lead to cake collapse, product degradation, and reduced shelf life. The aim of this study was to develop a fast, noninvasive, nondestructive, and inexpensive method for determining the moisture content in a lyophilized monoclonal antibody (mAb) formulation using benchtop low‐field time‐domain nuclear magnetic resonance spectroscopy. Determining the moisture content in lyophilized solids is a fundamental step towards predicting the quality and stability of lyophilized products, but conventional methods are time‐consuming, invasive, and destructive. High levels of residual moisture in a lyophilized product can lead to cake collapse, product degradation, and reduced shelf life. The aim of this study was to develop a fast, noninvasive, nondestructive, and inexpensive method for determining the moisture content in a lyophilized monoclonal antibody (mAb) formulation using benchtop low‐field time‐domain nuclear magnetic resonance spectroscopy.