Siemens Medical Solutions USA, Inc.

California Institute of Technology

Trace-Ability, Inc.

University of California

Fluidigm Corporation

Eli Lilly and Company

Arkadij M Elizarov

Hartmuth C Kolb

Carroll Edward Ball

Jianzhong Zhang

Artem Y Lebedev

Reza Miraghaie

James R Heath

R Michael Van Dam

Sean Ford

Todd L Graves

Michael Van Dam

Lawrence Diener

Stephen R Quake

Joseph C Walsh

Umesh B Gangadharmath

Hsian-Rong Tseng

Antoine Daridon

Jiang Huang

Michael E Phelps

Paul Wyatt

Keith E Schleiffer

Chung-cheng Lee

Guodong Sui

Ricardo Rodriguez

Robert Michael Van Dam

A method for determining a concentration of a synthesis component in a radiopharmaceutical sample comprises providing an indicator, a metal or a metal complex, contacting the radiopharmaceutical sample with the indicator, metal or metal complex for a period of time sufficient to obtain an interaction, measuring an optical characteristic of the interacted components, and determining a concentration of the synthesis component in the radiopharmaceutical sample based on the measured optical characteristic.

Method for determining a concentration of a synthesis component in a radiopharmaceutical sample

A method of determining a radioactivity characteristic of a radioactive sample comprises positioning the radioactive sample on a plate, positioning the plate containing the radioactive sample in an optical plate reader, obtaining luminescence data via the optical plate reader based on light emitted from the plate containing the radioactive sample, and determining a radioactivity characteristic of the radioactive sample based on the luminescence data.

Method of determining radiation characteristic of a sample

A device for automated characterization of radioactive analytes that provides an integrated system with liquid handling and plate reading components. The device can be further configured to include a chromatographic subsystem. Also provided is a method of using such a device, providing addition of a radioactive sample and a sequence of operations involving the abovementioned components of the system. The system is configured with radiation shielding in such a way that manipulations of radioactive samples do not interfere with concurrent radioactive measurements.

Systems and methods for characterizing radioactive analytes

Systems, devices, and methods are provided that facilitate synthesis and analysis of chemical compounds on a convenient and automatable palette-based platform. Palettes utilized for analysis support a variety of functional sites, including test wells, separation devices, and test sites that have rapid thermal equilibration, on a single test fixture. This permits both the performance of a wide variety of tests and of tests with different temperature requirements or responses in parallel, on the same test fixture. Such systems, devices, and methods are particularly suitable for production and characterization of radiopharmaceuticals.

Palette-based systems for analyte characterization

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

A system and method for performing radiochemical synthesis, analysis and/or dispensing of radiopharmaceuticals using specially designed disposable components: palettes and caddies, the palette being an assembly of containers not connected with each other for direct material transfer; the caddy being a disposable component used to transfer material between containers on the palettes and/or other locations.

System and method for radiosynthesis, quality control and dose dispensing

Described herein are automated, integrated microfluidic device comprising a chemical reaction chip comprising for performing chemical reaction, a microscale column integrated with the chip and configured for liquid flow from the column to at least one flow channel, and wherein the fluid flow into the column is controlled by on-chip valves; and comprising at least two on-chip valves for controlling fluid flow in the microfluidic device.

Microfluidic chip capable of synthesizing radioactively labeled molecules on a scale suitable for human imaging with positron emission tomography

Mechanical actuation of valves in flexible fluidic structures allows for the regulation of fluid flow. In accordance with the disclosure herein, a fluidic structure is provided wherein mechanical actuation is conferred using a pin to actuate a flexible layer to occlude fluid flow in a fluid channel.

Method and apparatus for the mechanical actuation of valves in fluidic devices

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

New microfluidic devices, useful for carrying out chemical reactions, are provided. The devices are adapted for on-chip solvent exchange, chemical processes requiring multiple chemical reactions, and rapid concentration of reagents.

Microfluidic chemical reaction circuits

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.

Growing community of inventors

Woodland Hills, CA, United States of America

Arkadij M Elizarov