Abstract: Microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, ten (10) unit doses of radiopharmaceutical biomarker for use in positron emission tomography (PET). A radioisotope from an accelerator or other radioisotope generator is introduced into a reaction vessel, along with organic and aqueous reagents, and the mixture heated to synthesize a solution of a pre-selected radiopharmaceutical. The solution is purified by passing through a combination of solid phase extraction purification components, trap and release components, and a filter. The synthesis process reduces waste and allows for production of biomarker radiopharmaceuticals on site and close to the location where the unit dose will be administered to the patient.

Abstract: A target assembly to produce radioisotopes for the synthesis of radiopharmaceuticals. The target assembly includes a target vessel with a target chamber adapted to receive a target material. A thin cover sheet of particle-permeable material covers the target chamber. In a bombardment process, a high-energy particle beam generated by a cyclotron or particle accelerator strikes the thin cover sheet, whereby at least some of the particles from the particle beam penetrate to the target chamber so as to interact with the target material, altering the nuclear makeup of some of the atoms in the target material to produce radioisotopes.

Abstract: A self-referencing radiation detector to test the radiochemical purity of a sample radiopharmaceutical solution. In some embodiments, the self-referencing radiation detector measures the radioactivity of a sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through a high performance liquid chromatography column. The radiation detector then measures the radioactivity of each separated molecularly distinct species from the high performance liquid chromatography column. The radiochemical purity of the sample radiopharmaceutical solution is calculated by comparing the measured radioactivity of separated molecularly distinct species from said high performance liquid chromatography column to the measured radioactivity of the sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through the high performance liquid chromatography column.

Abstract: A self-referencing radiation detector to test the radiochemical purity of a sample radiopharmaceutical solution. In some embodiments, the self-referencing radiation detector measures the radioactivity of a sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through a high performance liquid chromatography column. The radiation detector then measures the radioactivity of each separated molecularly distinct species from the high performance liquid chromatography column. The radiochemical purity of the sample radiopharmaceutical solution is calculated by comparing the measured radioactivity of separated molecularly distinct species from said high performance liquid chromatography column to the measured radioactivity of the sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through the high performance liquid chromatography column.

Abstract: HPLC-based quality control systems to perform quality control testing on a radiopharmaceutical solution shortly after synthesis. An HPLC-based quality control system makes efficient use of sample volume and is compatible with a variety of radioisotopes and radiopharmaceutical compounds. In several embodiments, the automated nature of an HPLC-based quality control system allows for quality control tests to be conducted quickly and with minimal impact on user workflow. When used as part of an integrated PET biomarker radiopharmaceutical production system, the present general inventive concept permits a manufacturer to produce product and conduct quality control tests with lower per dose costs.

Abstract: A target assembly to produce radioisotopes for the synthesis of radiopharmaceuticals. The target assembly includes a target vessel with a target chamber adapted to receive a target material. A thin cover sheet of particle-permeable material covers the target chamber. In a bombardment process, a high-energy particle beam generated by a cyclotron or particle accelerator strikes the thin cover sheet, whereby at least some of the particles from the particle beam penetrate to the target chamber so as to interact with the target material, altering the nuclear makeup of some of the atoms in the target material to produce radioisotopes.

Abstract: A microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography (PET). The radiopharmaceutical production system includes a reaction vessel that receives a radioisotope from an accelerator or other radioisotope generator. Organic and aqueous reagents are introduced into the reaction vessel, and the mixture is heated to synthesize a solution of a pre-selected radiopharmaceutical. The radiopharmaceutical solution is purified by passing the solution through a solid phase extraction column and a filter. The synthesis process produces per run a quantity of radiopharmaceutical approximately equal to, but not less than, one (1) unit dose of a radiopharmaceutical, reducing waste and allowing for the production of radiopharmaceutical on an as-needed basis.

Abstract: An improved biomarker generator and a method suitable for efficiently producing short lived radiopharmaceuticals in quantities on the order of a unit dose. The improved biomarker generator includes a particle accelerator and a radiopharmaceutical micro-synthesis system. The micro-accelerator of the improved biomarker generator is optimized for producing radioisotopes useful in synthesizing radiopharmaceuticals in quantities on the order of one unit dose allowing for significant reductions in size, power requirements, and weight when compared to conventional radiopharmaceutical cyclotrons.