Abstract: Provided herein are devices, systems, and methods for the removal of preservatives/excipients/stabilizers from pharmaceutical preparations/medicaments. The devices and systems include a resin for the filtering of preservatives from pharmaceutical preparations. The methods allow for a period of time of incubation of the pharmaceutical preparation in the resin that effectively removes preservatives, while at the same time maintaining the required amount or concentration of active compound in the preparation. Also provided herein are devices, systems, and methods for the controlled release of anti-inflammatory agents in an insulin infusion set.

Abstract: Provided herein are devices, systems, and methods for the removal of preservatives/excipients/stabilizers from pharmaceutical preparations/medicaments. The devices and systems include a resin for the filtering of preservatives from pharmaceutical preparations. The methods allow for a period of time of incubation of the pharmaceutical preparation in the resin that effectively removes preservatives, while at the same time maintaining the required amount or concentration of active compound in the preparation. Also provided herein are devices, systems, and methods for the controlled release of anti-inflammatory agents in an insulin infusion set.

Abstract: Methods for adhering a hydrogel matrix to a molded polymer substrate and its use as a biosensor, e.g., a continuous or episodic glucose monitor, are disclosed. The presently disclosed subject mater provides a method for adhering a hydrogel matrix to a molded polymer substrate, the method comprising; (a) molding a polymer comprising one or more polymer chains with an oxidizer to form a molded polymer substrate; (b) providing a hydrogel matrix comprising a hydrogel, a component comprising one or more acrylate groups or another functional group that can form one or more radicals upon polymerization in the molded polymer substrate, and a photo initiator; (c) combining the molded polymer substrate and the hydrogel matrix; and (d) curing the combined molded polymer substrate and hydrogel matrix for a period of fime.

Abstract: Methods for adhering a hydrogel matrix to a molded polymer substrate and its use as a biosensor, e.g., a continuous or episodic glucose monitor, are disclosed. The presently disclosed subject matter provides a method for adhering a hydrogel matrix to a molded polymer substrate, the method comprising: (a) molding a polymer comprising one or more polymer chains with an oxidizer to form a molded polymer substrate; (b) providing a hydrogel matrix comprising a hydrogel, a component comprising one or more acrylate groups or another functional group that can form one or more radicals upon polymerization in the molded polymer substrate, and a photo initiator; (c) combining the molded polymer substrate and the hydrogel matrix; and (d) curing the combined molded polymer substrate and hydrogel matrix for a period of time.

Abstract: A container and method for storing a pharmaceutical agent are provided for enhancing the storage time. The storage time of the pharmaceutical agent is improved by reducing the loss of stabilizing agents in the pharmaceutical agent. The storage container is formed from a polyolefin that includes a stabilizing agent in an amount effective to reduce or inhibit the migration of stabilizing agents in the pharmaceutical agent. The polyolefin container is formed with a fatty acid amide such as erucamide for stabilizing insulin that contains m-cresol and/or phenol as stabilizing agents for the insulin. The fatty acid amide incorporated in the container inhibits and/or reduces the rate of migration of the m-cresol and/or phenol into the polyolefin to extend the storage life of the insulin. The container can be a syringe, such as a pre-filled syringe, a storage vial or the flow path of an infusion pump.

Abstract: Methods and compositions for preparing dry formulations of Glucose Binding Proteins (GBPs) are disclosed. The GBPs may be stored as a dry formulation without significant loss of activity. After reconstitution, the GBPs may be used to determine the glucose concentration of a sample.

Abstract: Methods for adhering a hydrogel matrix to a molded polymer substrate and its use as a biosensor, e.g., a continuous or episodic glucose monitor, are disclosed. The presently disclosed subject matter provides a method for adhering a hydrogel matrix to a molded polymer substrate, the method comprising: (a) molding a polymer comprising one or more polymer chains with an oxidizer to form a molded polymer substrate; (b) providing a hydrogel matrix comprising a hydrogel, a component comprising one or more acrylate groups or another functional group that can form one or more radicals upon polymerization in the molded polymer substrate, and a photo initiator; (c) combining the molded polymer substrate and the hydrogel matrix; and (d) curing the combined molded polymer substrate and hydrogel matrix for a period of time.

Abstract: A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. A sensing element is attached to the distal end of an optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the optical conduit and sensing element may be housed within a cannulated bevel.

Abstract: A container and method for storing a pharmaceutical agent are provided for enhancing the storage time. The storage time of the pharmaceutical agent is improved by reducing the loss of stabilizing agents in the pharmaceutical agent. The storage container is formed from a polyolefin that includes a stabilizing agent in an amount effective to reduce or inhibit the migration of stabilizing agents in the pharmaceutical agent. The polyolefin container is formed with a fatty acid amide such as erucamide for stabilizing insulin that contains m-cresol and/or phenol as stabilizing agents for the insulin. The fatty acid amide incorporated in the container inhibits and/or reduces the rate of migration of the m-cresol and/or phenol into the polyolefin to extend the storage life of the insulin. The container can be a syringe, such as a pre-filled syringe, a storage vial or the flow path of an infusion pump.

Abstract: A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. A sensing element is attached to the distal end of an optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the optical conduit and sensing element may be housed within a cannulated bevel.

Abstract: A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. An optical conduit, preferably an optical fiber has an optical system at the proximal end of the optical conduit. A sensing element is attached to the distal end of the optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the sensing element includes reference groups with luminescence properties that are substantially unchanged by variations in the analyte concentrations.

Abstract: A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. A sensing element is attached to the distal end of an optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the optical conduit and sensing element may be housed within a cannulated bevel.

Abstract: The invention is directed to entrapped mutated binding proteins, mutated binding proteins containing reporter groups, compositions of mutated binding proteins containing reporter groups in analyte permeable matrixes, and their use as analyte biosensors both in vitro and in vivo.

Abstract: The present invention relates to methods of making a sterilized biosensor, where the biosensor comprises at least one binding reagent, which comprises at least one non-enzyme proteinaceous binding domain. Certain embodiments of the methods described herein comprise partially assembling the components of the biosensor, except for the binding reagent, and separately sterilizing this partial assemblage and the binding reagent. The sterilized binding reagent and the sterilized partial assemblage are then aseptically assembled to produce the sterilized biosensor. Other embodiments of the methods described herein comprise assembling substantially all of the components of the biosensor, including the binding reagent, and sterilizing the assembled biosensor to produce a sterilized biosensor.

Abstract: A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is described. An optical conduit, preferably an optical fiber, has an optical system at the proximal end of the optical conduit. A sensing element is attached to the distal end of the optical conduit, and may include at least one binding protein adapted to bind with at least one target analyte. The sensing element further may also include at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the sensing element includes reference groups with luminescence properties that are substantially unchanged by variations in the analyte concentrations.

Abstract: The invention relates to methods and devices for measuring blood glucose levels in a subject, where the methods and devices are designed for exposing a sensing mechanism to interstitial fluid in the subject.

Abstract: A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. An optical conduit, preferably an optical fiber has an optical system at the proximal end of the optical conduit. A sensing element is attached to the distal end of the optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the sensing element includes reference groups with luminescence properties that are substantially unchanged by variations in the analyte concentrations.

Abstract: The present invention relates to methods of making a sterilized biosensor, where the biosensor comprises at least one binding reagent, which comprises at least one non-enzyme proteinaceous binding domain. Certain embodiments of the methods described herein comprise partially assembling the components of the biosensor, except for the binding reagent, and separately sterilizing this partial assemblage and the binding reagent. The sterilized binding reagent and the sterilized partial assemblage are then aseptically assembled to produce the sterilized biosensor. Other embodiments of the methods described herein comprise assembling substantially all of the components of the biosensor, including the binding reagent, and sterilizing the assembled biosensor to produce a sterilized biosensor.

Abstract: The invention is directed to binding proteins, proteins comprising reporter groups, compositions of binding molecules comprising reporter groups in analyte permeable matrices, and their use as analyte biosensors both in vitro and in vivo.

Abstract: A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. A sensing element is attached to the distal end of an optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the optical conduit and sensing element may be housed within a cannulated bevel.