Real-time in situ monitoring of drug product degradation using water proton NMR

A method of determining if an aqueous-based drug product has experienced substantial oxidation at some point during manufacturing, storage, and/or distribution chain, wherein the aqueous-based drug product comprises biologics, said method comprising:

• measuring a transverse relaxation rate of water, R2m, in the aqueous-based drug product using water proton nuclear magnetic resonance (wNMR), wherein the aqueous-based drug product is contained in a filled and sealed vial and wherein the R2m, is measured without opening the vial and without adding any additives to the vial prior to measurement of the R2m;
• and
• determining if the aqueous-based drug product has undergone substantial oxidation by comparing the measured R2m to a reference transverse relaxation rate of water R2r, wherein the reference R2r represents an acceptable range for substantially non-oxidized aqueous-based drug product, wherein when the measured R2m is inside the reference R2r range, the aqueous-based drug product has not experienced substantial oxidation and the vial remains in the manufacturing, storage, or distribution chain, and when the measured R2m is less than the reference R2r range, the aqueous-based drug product has experienced substantial oxidation and the vial is removed from the manufacturing, storage, or distribution chain.