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

Anuji Abraham; Omar Elkassabany; Mary E Krause; Andrew Ott

doi:10.1002/mrc.4864

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

Magn Reson Chem. 2019 Aug;57(10):873-877. doi: 10.1002/mrc.4864. Epub 2019 Apr 29.

Authors

Anuji Abraham¹, Omar Elkassabany¹, Mary E Krause¹, Andrew Ott¹

Affiliation

¹ Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, New Jersey.

PMID: 30861192
DOI: 10.1002/mrc.4864

Abstract

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.

Keywords: TD NMR spectroscopy; freeze-dried product; low-field NMR; lyophilization; moisture content; water content.