Siemens Medical Solutions Usa, Inc.

Eli Lilly and Company

Carroll Edward Ball

Hartmuth C Kolb

Arkadij M Elizarov

Jianzhong Zhang

Reza Miraghaie

R Michael Van Dam

Sean Ford

Artem Y Lebedev

Todd L Graves

Lawrence Diener

Joseph C Walsh

Umesh B Gangadharmath

Ricardo Rodriguez

Keith E Schleiffer

Robert Michael Van Dam

A system, apparatus, and method for transferring chemical solutions and synthesizing a tracer. For transferring chemical solutions, the system comprises a primary container; a secondary container; a first line in communication with the primary container and the secondary container. The first line facilitates the flow of gas and/or liquid between the primary container and the secondary container. A valve located upstream of the secondary container and downstream of the primary container regulates flow within the first line; a second line in communication with the secondary container. For synthesizing a tracer, the system includes a source of a solution having a radionuclide. A first container has a tracer precursor and is in communication with the source of solution.

System, device and method for preparing tracers and transferring materials during radiosynthesis

Macro- and microfluidic devices and related technologies, and chemical processes using such devices. More specifically, the devices may be used for a fully automated synthesis of radioactive compounds for imaging, such as by positron emission tomography (PET), in an efficient, compact and safe to the operator manner. In particular, embodiments of the present invention relate to an automated, multi-run, microfluidic instrument for the multi-step synthesis of radiopharmaceuticals, such as PET probes, comprising a remote shielded mini-cell containing radiation-handing components.

Modular system for radiosynthesis with multi-run capabilities and reduced risk of radiation exposure

Methods and apparatus to assess current aspects of Quality Control useful for release of radioactive compounds for imaging, such as PET tracers as injectables, in an automated manner, without user interference, and in compliance with regulatory guidelines. The present method and system relates to an integrated automated quality control analysis of a substance utilizing a single sample injection for a plurality of inline quality control tests. A quantitative analysis of the sample via the plurality of quality control tests is conducted. A measurement value of each of the plurality of quality control parameters is determined and a comparison of each measurement value of the plurality of quality control parameters with a predetermined corresponding criterion value is made. A cumulative quality rating for the sample is determined and the validated sample is released based on the quality rating.

Apparatus and method for automated quality control

Methods and devices for a fully automated synthesis of radioactive compounds for imaging, such as by positron emission tomography (PET), in a fast, efficient and compact manner are disclosed. In particular, the various embodiments of the present invention provide an automated, stand-alone, hands-free operation of the entire radiosynthesis cycle on a microfluidic device with unrestricted gas flow through the reactor, starting with target water and yielding purified PET radiotracer within a period of time shorter than conventional chemistry systems. Accordingly, one aspect of the present invention is related to a microfluidic chip for radiosynthesis of a radiolabeled compound, comprising a reaction chamber, one or more flow channels connected to the reaction chamber, one or more vents connected to said reaction chamber, and one or more integrated valves to effect flow control in and out of said reaction chamber.

Portable microfluidic radiosynthesis system for positron emission tomography biomarkers and program code

Methods and apparatus for facilitating the synthesis of compounds in a batch device are presented. Application of the batch type microfluidic devices to the synthesis of radiolabeled compounds is described. These methods and apparatus enable the selective introduction of multiple reagents via an enhanced rotary flow distribution valve through a single inlet port of the synthetic device. The sequential introduction of multiple reagents through a single inlet port allows an optimal delivery of highly concentrated reagents into the reactor and facilitates the synthesis of the desired products with a minimal loss of materials during transfers, which is critical to the synthesis of radiolabeled biomarkers.

Apparatus and method using rotary flow distribution mechanisms

Microfluidic radiosynthesis system for positron emission tomography biomarkers

The present application relates to microfluidic devices and related technologies, and to chemical processes using such devices. More specifically, the application discloses a fully automated synthesis of radioactive compounds for imaging, such as by positron emission tomography (PET), in a fast, efficient and compact manner. In particular, this application describe an automated, stand-alone, microfluidic instrument for the multi-step chemical synthesis of radiopharmaceuticals, such as probes for PET and a method of using such instruments.

Fully-automated microfluidic system for the synthesis of radiolabeled biomarkers for positron emission tomography

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Los Angeles, CA, United States of America

Carroll Edward Ball