Biopharmaceutical aggregation assessment and counterfeit detection using magnetic resonance relaxometry
AssigneeUniversity of Maryland, Baltimore
InventorsYihua Bruce YU, Marc Taraban, Yue Feng
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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.
Claims15
-9. (canceled)
A method of detecting whether a composition is a counterfeit of a proprietary composition, said method comprising:
- measuring a relaxation dispersion profile R(ω) of the composition, wherein the composition is contained in a vial;
- and comparing the measured R(ω) of the composition to a standard R(ω) for the proprietary composition, wherein the composition is a counterfeit if the measured R(ω) is greater than an indicated percent difference from the standard R(ω), wherein the indicated percent difference is provided by the manufacturer of the proprietary composition, and wherein the measurement of the relaxation dispersion profile R(ω) is done without opening the vial or otherwise accessing the contents of the vial containing the composition.
A method of determining if a biopharmaceutical-containing product remains viable, said method comprising:
- measuring the transverse relaxation rate of water R2 of the biopharmaceutical-containing product, wherein the biopharmaceutical-containing product is contained in a vial;
- determining the extent of aggregation of the biopharmaceutical-containing product by extrapolating a standard extent of aggregation calibration curve;
- and comparing the determined extent of aggregation of the biopharmaceutical-containing product to the maximum acceptable extent of aggregation for said product, wherein if the extent of aggregation of the biopharmaceutical-containing product is less than the maximum acceptable extent of aggregation for said product then the biopharmaceutical-containing product remains viable, and wherein the water R2 is measured without opening the vial or otherwise accessing the contents of the vial containing the biopharmaceutical-containing product.
Dependencies are inferred from the claim text.