Abstract: Drug delivery devices and associated heating and/or cooling devices are disclosed. In an example, a drug delivery device includes a housing, a container, a therapy layer, and a first adhesive layer. The housing includes a top wall and a bottom wall. The container is at least partially disposed within the housing. The container has an inner volume to contain a drug. The therapy layer have a first side and a second side. The first side faces the bottom wall and the second side faces away from the bottom wall. The first adhesive layer couples the first side of the therapy layer and the bottom wall. The therapy layer is adapted to at least one of heat or cool an area adjacent an injection site.

Abstract: A method of sterilizing biocontainers including irradiating a biocontainer and measuring a radiation dose received by the biocontainer. The method also includes determining an ageing time of the biocontainer after irradiation based on the radiation dose received by the biocontainer and preventing use of the biocontainer before the ageing time has elapsed.

Abstract: A radiation dose sensor that measures a radiation dose of a biocontainer formed for a first material includes a first electrode, a second electrode, and a film. The first electrode has a plurality of first fingers. And the second electrode has a plurality of second fingers. The fingers of the first electrode extend towards and are interdigitated with the fingers of the second electrode that extend towards the first electrode with gaps formed between the first and second fingers. The film coats the interdigitated fingers and is disposed within the gaps. The film is formed of a second material that is similar to the first material that forms the biocontainer.

Abstract: A method of measuring a radiation dosage during irradiation includes disposing a first sensor in a first package with a first biocontainer and disposing a second sensor in a second package with a second biocontainer. The method further includes placing the first package and the second package in a container and irradiation the container including the first package and the second package. During or after irradiation, a first radiation dosage associated with the first biocontainer is measured with the first sensor and a second radiation dosage associated with the second biocontainer is measured with the second sensor.

Abstract: Systems and methods for characterizing a plurality of particles suspended in a solution are described. In some embodiments, an ultrasonic interrogation signal may be emitted into a solution including a plurality of particles suspended in the solution. A resulting ultrasonic spectrum may be sensed and provided to a trained statistical model of the solution. The trained statistical model may then determine one or more properties of the plurality of particles.

Abstract: A drug delivery device includes a housing, a container disposed in the housing, an activation mechanism, a needle insertion mechanism, and a fluid flow path. The container has an inner volume to contain a medicament which is urged out of the container by the activation mechanism. The needle insertion mechanism includes an actuation assembly adapted to insert a needle and a cannula to deliver the medicament from the container and a valve assembly. The fluid flow connection is coupled with the container and the needle insertion mechanism and is adapted to allow the medicament to flow from the container to the needle insertion mechanism. The valve assembly is repeatedly movable between at least a valve open position and a valve closed position to selectively allow and restrict the medicament to flow through the needle and/or the cannula.

Abstract: A cassette for a drug delivery device is described that includes a sleeve, a syringe having a barrel disposed in the sleeve, and a plunger-stopper slidably disposed within the barrel. The cassette further includes a spacer that is configured to be coupled to the sleeve. The cassette can form a part of an apparatus for injection of a therapeutic product along with a drug delivery device.

Abstract: A drug delivery device includes a housing defining a shell and an inner volume, a container, a drive mechanism, a needle assembly, a fluid flow connection, and a backflow prevention mechanism. The container has an inner volume to contain a medicament to be administered to a user. The drive mechanism is at least partially disposed within the housing and exerts a force to urge the medicament out the container. The fluid flow connection is coupled to the container and the needle assembly and allows the medicament to flow from the container to the needle assembly to be administered. The backflow prevention mechanism is associated with at least one of the container, the fluid flow connection, or the needle assembly and includes at least one flow restrictor to restrict a fluid from flowing from the needle assembly to the container.

Abstract: The present invention relates to isolated nucleic acid molecules, comprising a functional mammalian EGR-1 (early growth response protein 1) promoter region that is operatively linked to a gene encoding a fluorescent protein and controls expression of said gene. The present invention further relates to nucleic acid vectors, comprising said nucleic, cells comprising said nucleic acids or vectors, being capable of sensing and indicating fluid shear stress acting on themselves, and methods of generating the same. Furthermore, the present invention relates to methods of evaluating fluid shear stress acting on cells in real-time during the operation of a biotechnological device or system, methods of evaluating a biotechnological device or system with respect to fluid shear stress acting on cells caused by operation of said device or system, and methods of designing a biotechnological device or system, said methods using said cells.

Abstract: A syringe is described with a plunger assembly that is adapted to have a dispensing stroke sized to dispense a fluid therapeutic product from the syringe without dispensing any air or headspace. The syringe includes a plunger rod having a stop feature that stops a dispensing stroke of the plunger rod at a distance corresponding to a level of air or headspace within the syringe avoiding additional air dispensing steps from a healthcare provider.

Abstract: Fluidic modules configured for flowing fluid through membranes and associated methods are generally provided. In some embodiments, a fluidic module comprises two channels between which a membrane is positioned. The two channels may have geometries such that the pressure drop experienced by a fluid flowing from the first channel, through the membrane, and into the second channel is substantially independent of the location along the channel at which it flows through the membrane. In other words, the pressure drop may be substantially constant over the membrane area.

Abstract: Methods for forming arrays of droplets, and associated arrays of droplets, are generally provided.

Abstract: A drug delivery device includes a housing, a container disposed in the housing, an activation mechanism, and a needle insertion mechanism (NIM). The container has an inner volume to contain a medicament which is urged out of the container by the activation mechanism. The needle insertion mechanism (NIM) is operably coupled with the activation mechanism and includes an actuation assembly adapted to insert a needle and a cannula to deliver the medicament from the container. The actuation assembly is movable between a storage state, a first operational state, a second operational state, and a third operational state to selectively position the needle and the cannula.

Abstract: Drug delivery devices and associated heating and/or cooling devices are disclosed. In an example, a drug delivery device includes a housing, a container, a therapy layer, and a first adhesive layer. The housing includes a top wall and a bottom wall. The container is at least partially disposed within the housing. The container has an inner volume to contain a drug. The therapy layer have a first side and a second side. The first side faces the bottom wall and the second side faces away from the bottom wall. The first adhesive layer couples the first side of the therapy layer and the bottom wall. The therapy layer is adapted to at least one of heat or cool an area adjacent an injection site.

Abstract: A drug delivery device includes a housing defining a shell and an inner volume, a container, a drive mechanism, a needle assembly, a fluid flow connection, and a backflow prevention mechanism. The container has an inner volume to contain a medicament to be administered to a user. The drive mechanism is at least partially disposed within the housing and exerts a force to urge the medicament out the container. The fluid flow connection is coupled to the container and the needle assembly and allows the medicament to flow from the container to the needle assembly to be administered. The backflow prevention mechanism is associated with at least one of the container, the fluid flow connection, or the needle assembly and includes at least one flow restrictor to restrict a fluid from flowing from the needle assembly to the container.