Abstract: A method of using the transverse relaxation time (T2) of solvent NMR signal to detect filling errors of an alum-containing product in real-time and in-line during manufacturing, for example during a fill-finish unit operation. This method 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 noninvasively assess whether viral capsids in a capsid preparation are full or empty, and the percentage of full capsids if the vial contains a mixture of full and empty capsids. The method can simply, rapidly, and non-invasively prove the safety and potency of the capsid preparation and thus whether the capsid preparation can be approved for clinical use, without requiring any sample preparation or reagent addition.

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: Methods for non-invasively identifying substandard or counterfeit products, e.g., vaccines, using nuclear magnetic resonance. The methods provide manufacturers with new approaches to identify parameters to assist users with the identification of substandard or counterfeit products.

Abstract: A method of using the transverse relaxation rate (R2) of solvent NMR signal to noninvasively assess alum-containing products such as vaccines. This technique can be used for quality control in vaccine manufacturing (e.g., fill-finish step) to determine the evenness of alum filling level as well as extent of alum particle sedimentation in filled and sealed products.

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 noninvasively assess alum-containing products such as vaccines. This technique can be used for quality control in vaccine manufacturing (e.g., fill-finish step) to determine the evenness of alum filling level as well as extent of alum particle sedimentation in filled and sealed products.

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 noninvasively assess whether viral capsids in a capsid preparation are full or empty, and the percentage of full capsids if the vial contains a mixture of full and empty capsids. The method can simply, rapidly, and non-invasively prove the safety and potency of the capsid preparation and thus whether the capsid preparation can be approved for clinical use, without requiring any sample preparation or reagent addition.

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: The present invention generally relates to a method of using NMR relaxation rates (R2) of water molecules as an indicator of the extent of aggregation of biopharmaceutical formulations. The biopharmaceutical can be evaluated nondestructively without the vial or container being opened or protective seal compromised (i.e., broken). The method is applicable to all biopharmaceuticals and the water signal obtained by magnetic resonance relaxometry is very strong and sensitive because water is used as the solvent and is present in high (>90%) concentrations in every biopharmaceutical formulation.

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: The present invention generally relates to a method of using NMR relaxation rates (R2) of water molecules as an indicator of the extent of aggregation of biopharmaceutical formulations. The biopharmaceutical can be evaluated nondestructively without the vial or container being opened or protective seal compromised (i.e., broken). The method is applicable to all biopharmaceuticals and the water signal obtained by magnetic resonance relaxometry is very strong and sensitive because water is used as the solvent and is present in high (>90%) concentrations in every biopharmaceutical formulation.

Abstract: The present invention generally relates to a method of using NMR relaxation rates (R2) of water molecules as an indicator of the extent of aggregation of biopharmaceutical formulations. The biopharmaceutical can be evaluated nondestructively without the vial or container being opened or protective seal compromised (i.e., broken). The method is applicable to all biopharmaceuticals and the water signal obtained by magnetic resonance relaxometry is very strong and sensitive because water is used as the solvent and is present in high (>90%) concentrations in every biopharmaceutical formulation.

Abstract: A method of using the transverse relaxation rate (R2) of solvent NMR signal to noninvasively assess alum-containing products such as vaccines. This technique can be used for quality control in vaccine manufacturing (e.g., fill-finish step) to determine the evenness of alum filling level as well as extent of alum particle sedimentation in filled and sealed products.

Abstract: The present invention generally relates to a method of using NMR relaxation rates (R2) of water molecules as an indicator of the extent of aggregation of biopharmaceutical formulations. The biopharmaceutical can be evaluated nondestructively without the vial or container being opened or protective seal compromised (i.e., broken). The method is applicable to all biopharmaceuticals and the water signal obtained by magnetic resonance relaxometry is very strong and sensitive because water is used as the solvent and is present in high (>90%) concentrations in every biopharmaceutical formulation.

Abstract: The present invention generally relates to a method of using NMR relaxation rates (R2) of water molecules as an indicator of the extent of aggregation of biopharmaceutical formulations. The biopharmaceutical can be evaluated nondestructively without the vial or container being opened or protective seal compromised (i.e., broken). The method is applicable to all biopharmaceuticals and the water signal obtained by magnetic resonance relaxometry is very strong and sensitive because water is used as the solvent and is present in high (>90%) concentrations in every biopharmaceutical formulation.

Abstract: The present invention generally relates to a method of using NMR relaxation rates (R2) of water molecules as an indicator of the extent of aggregation of biopharmaceutical formulations. The biopharmaceutical can be evaluated nondestructively without the vial or container being opened or protective seal compromised (i.e., broken). The method is applicable to all biopharmaceuticals and the water signal obtained by magnetic resonance relaxometry is very strong and sensitive because water is used as the solvent and is present in high (>90%) concentrations in every biopharmaceutical formulation.