Best Medical International, Inc.

Abt Molecular Imaging, Inc.

Atilio Anzellotti

Aaron McFarland

Clive Brown-Proctor

Daniel Hillesheim

Mark Haig Khachaturian

Doug Ferguson

Mark Khachaturian

Andrew Land

An automated radiopharmaceutical production and quality control system includes a particle accelerator, a radiopharmaceutical micro-synthesis subsystem, and quality control subsystem. The micro-accelerator of the improved biomarker generator is optimized for producing radioisotopes useful in synthesizing radiopharmaceuticals in quantities on the order of multiple unit doses, allowing for significant reductions in size, power requirements, and weight when compared to conventional radiopharmaceutical cyclotrons. The radiopharmaceutical micro-synthesis subsystem encompasses a small volume chemical synthesis system comprising a microreactor and/or a microfluidic chip and optimized for synthesizing the radiopharmaceutical in small quantities, allowing for significant reductions in processing time and in the quantity of radioisotope required. The automated quality control subsystem is used to test the composition and characteristics of the radiopharmaceutical to ensure that it is safe to inject.

Automated radiopharmaceutical production and quality control system

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. On-site, as-needed production of radiopharmaceuticals in small doses reduces the time between synthesis of the radiopharmaceutical and administration of that radiopharmaceutical, minimizing loss of active isotopes through decay and allowing production of lesser amounts of radioisotopes overall.

Dose synthesis card for use with automated biomarker production system

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Knoxville, TN, United States of America

Atilio Anzellotti