University System of Maryland

Access to Advanced Health Institute

Yihua (Bruce) Yu

Marc B Taraban

Christopher B Fox

Xuyi Yue

A method of using the transverse relaxation rate (R) of solvent NMR signal to noninvasively assess if an alum-containing product, such as a vaccine, has been acceptably resuspended for use following transport and/or storage. This technique allows for the manufacturer and/or distributor and/or end user to monitor for unexpected stressors associated with transport and/or storage including, but not limited to, temperature fluctuations, pH changes, vigorous shaking during transportation, exposure to sunlight, and freezing.

In situ determination of acceptable resuspension in pharmaceutical products using water proton NMR

A method of using the transverse relaxation time (T) 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.

In situ, real-time in-line detection of filling errors in pharmaceutical product manufacturing using water proton NMR

A method of using the relaxation rate (Rand/or R) 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.

Noninvasive quantitation of full versus empty capsids using water proton NMR

A method for using water proton transverse relaxation rate R(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.

Real-time in situ monitoring of suspension sedimentation using water proton NMR

A method of using the transverse relaxation rate (R) 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.

In situ determination of alum filling evenness and sedimentation in pharmaceutical products using water proton NMR

A method of using the transverse relaxation rate (R) 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.

The present invention provides for monodispersed dendrimers having a core, branches and periphery ends, wherein the number of branches increases exponentially from the core to the periphery end and the length of the branches increases exponentially from the periphery end to the core, thereby providing for attachment of chemical species at the periphery ends without exhibiting steric hindrance.

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Ellicott City, MD, United States of America

Yihua (Bruce) Yu