Abstract: A method for using water proton transverse relaxation rate R2(T) to monitor, in real time, the sedimentation rates of multiphase mixtures such as drug products and drug substances. The method provides a practical application of wNMR as an analytical tool to study and provide higher quality and more efficient multiphase mixtures.

Abstract: A method of using the transverse relaxation rate (R2) of solvent NMR signal to detect filling errors of an alum-containing product in real-time in-line during manufacturing, for example during a fill-finish unit operation. This technique can be used for quality control in vaccine manufacturing to ensure the delivery of the correct concentration of alum-containing product to the product container such as a vial or pre-filled syringe.

Abstract: A method of using the transverse relaxation rate (R2) of solvent NMR signal to detect filling errors of an alum-containing product in real-time in-line during manufacturing, for example during a fill-finish unit operation. This technique can be used for quality control in vaccine manufacturing to ensure the delivery of the correct concentration of alum-containing product to the product container such as a vial or pre-filled syringe.

Abstract: A method of using the relaxation rate (R1 and/or R2) of solvent NMR signal to invasively or noninvasively assess whether vaccines and other aqueous-based pharmaceutical products have been frozen during transport and/or storage.

Abstract: Provided herein are methods for using water proton transverse relaxation rate R2(T) to monitor in real time the sedimentation process of multiphase mixtures such as drug products and drug substances. Using wNMR (water proton nuclear magnetic resonance), valuable information can be obtained regarding sedimentation rate, dynamics of supernatant and sediment buildup, and sedimentation volume ratio (SVR) reflecting the compactness of formed sediment in such mixtures. The results described herein demonstrate the practical applicability of wNMR as an analytical tool to study and provide higher quality and more efficient multiphase mixtures.

Abstract: A method of using the relaxation rate (R1 and/or R2) of solvent NMR signal to assess whether drug products have undergone substantial chemical degradation during manufacturing, transport and/or storage. The monitoring can be performed under both static and flow conditions, in real-time and in a contact-free manner.

Abstract: A method of using the transverse relaxation rate (R2) of solvent NMR signal to detect filling errors of an alum-containing product in real-time in-line during manufacturing, for example during a fill-finish unit operation. This technique can be used for quality control in vaccine manufacturing to ensure the delivery of the correct concentration of alum-containing product to the product container such as a vial or pre-filled syringe.