A microfluidic device for storing a reagent includes a single unit includes a first portion having a reagent storage chamber configured to hold a reagent. The device also includes a second portion having a reaction chamber configured to support the reagent during a reaction process to form a product. The device also includes a valve configured to isolate the reagent storage compartment from the reaction chamber when the valve is in a closed state.

The automated synthesis of clinically relevant amounts of 16-.sup.18F-fluoro-5-dihydrotestosterone (.sup.18F-FDHT) using a commercially available radiosynthesizer. Synthesis was performed in 90 minutes with a decay-corrected radiochemical yield of 295%. The specific activity was 4.6 Ci/mol (170 GBq/mol) at end of formulation with a starting activity of 1.0 Ci (37 GBq). The formulated .sup.18F-FDHT yielded sufficient activity for multiple patient doses and passed all quality control tests required for routine clinical use.

Systems and methods for synthesizing chemical products, including active pharmaceutical ingredients, are provided. Certain of the systems and methods described herein are capable of manufacturing multiple chemical products without the need to fluidically connect or disconnect unit operations when switching from one making chemical product to making another chemical product.

A test method and test apparatus is provided that employs a microfluidic device to characterize properties of a fluid. The microfluidic device has a first inlet port, an outlet port, and a microchannel as part of a fluid path between the first inlet port and the outlet port. While generating a flow of the fluid through the microchannel of the microfluidic device, fluid pressure at the first inlet port of the microfluidic device is measured and recorded in conjunction with varying the controlled temperature of the microchannel of the microfluidic device to characterize the properties of the fluid that flows through the microchannel of the microfluidic device. The properties of the fluid can relate to the clathrate hydrate formation condition of the fluid at the pressure of the flow through the microchannel of the microfluidic device.

A drug provision system includes a slot to which a kit can be attached and detached, the kit including a raw ingredient space into which a raw ingredient of a drug is filled and a reactor for mixing the raw ingredient that flows from the raw ingredient space with another raw ingredient; a raw ingredient feeding mechanism that moves the raw ingredient within the raw ingredient space to the reactor in the kit in which a blocking unit has been released to mix the raw ingredients within the kit; and a collection mechanism that collects a drug within the reactor prepared by mixing the raw ingredients from the kit.

Embodiments described herein provide micro-fluidic systems and devices for use in performing various diagnostic and analytical tests. According to one embodiment, the micro-fluidic device includes a sample chamber for receiving a sample, and a reaction chamber for performing a chemical reaction. A bubble jet pump is structured on the device to control delivery of a fluid from the sample chamber to the reaction chamber. The pump is fluidically coupled to one or more chambers of the device using a fluidic channel such as a capillary. A valve may be coupled to one or more chambers to control flow into and out of those chambers. Also, a sensor may be positioned in one or more of the chambers, such as the reactant chamber, for sensing a property of the fluid within the chamber as well as the presence of a chemical within the chamber.

The present disclosure is directed towards improved systems and methods for large-scale production of nanoparticles used for delivery of therapeutic material. The apparatus can be used to manufacture a wide array of nanoparticles containing therapeutic material including, but not limited to, lipid nanoparticles and polymer nanoparticles. In certain embodiments, continuous flow operation and parallelization of microfluidic mixers contribute to increased nanoparticle production volume.

The present invention relates to an automated radiosynthesis device adapted for enhanced automatic disconnection of a disposable kit once a radiosynthesis has been carried out. The automated radiosynthesis device of the invention therefore reduces the time to remove the disposable kit from the radiosynthesis device and reduces radiation exposure to the operator.

A closed system for rehydrating powder and delivering the rehydrated powder to a reactor, may include a liquid reservoir for containing liquid; a syringe configured to contain powder to be rehydrated; a reactor; a controller for controlling operation of the syringe; and a conduit fluidically linking the liquid reservoir to a port of the syringe, fluidically linking the port to the reactor. The controller is configured to operate the syringe so as to draw liquid from the liquid reservoir into the syringe and rehydrate the powder, or to drive the rehydrated powder into the reactor.

The automated synthesis of clinically relevant amounts of 16-.sup.18F-fluoro-5-dihydrotestosterone (.sup.18F-FDHT) using a commercially available radiosynthesizer. Synthesis was performed in 90 minutes with a decay-corrected radiochemical yield of 295%. The specific activity was 4.6 Ci/mol (170 GBq/mol) at end of formulation with a starting activity of 1.0 Ci (37 GBq). The formulated .sup.18F-FDHT yielded sufficient activity for multiple patient doses and passed all quality control tests required for routine clinical use.