Devices and methods for radiopharmaceutical synthesis

A device for synthesizing a radioisotope-labelled target tracer, the device comprising:

• (a) a substrate and a microfluidic chip comprising a patterned layer on the substrate or an etched layer on the substrate, and a strong cation exchange (SCX) module, a strong anion exchange (SAX) module, and a passive in-plane mixing and reaction module, wherein
• the SCX module is configured to cationically concentrate and capture a radioisotope from a radioisotope solution delivered from a radioisotope generator, and release the captured radioisotope from the SCX module;
• the SAX module is in fluidic communication with the SCX module and is configured to anionically purify the released radioisotope;
• and
• the passive in-plane mixing and reaction module is in fluidic communication with the SAX module and is configured to mix the purified radioisotope and a target precursor and synthesize the radioisotope-labelled target tracer in the passive in-plane mixing and reaction module by performing a labelling reaction;
• (b) a heating means positioned proximate to the microfluidic chip for heating the microfluidic chip during the labelling reaction;
• and
• (c) a first valve fluidically coupled with the SCX module and the SAX module and a second valve fluidically coupled with the SAX module and the passive in-plane mixing and reaction module, the first valve and the second valve for operably controlling a first transit of various substances among the SCX module, the SAX module, and the passive in-plane mixing and reaction module or a second transit of various mixtures among the SCX module, the SAX module, and the passive in-plane mixing and reaction module, wherein the passive in-plane mixing and reaction module comprises a flow focusing means, a mixing channel and a reaction chamber, wherein the mixing channel comprises a mixing channel entrance and the flow focusing means is disposed at the mixing channel entrance and is configured to flow focus the purified radioisotope and the target precursor onto the mixing channel such that the purified radioisotope and the target precursor mix in the mixing channel and form a mixture for loading into the reaction chamber for performing the labelling reaction in the reaction chamber and wherein the flow focusing means comprises a target precursor inlet, a first radioisotope inlet and a second radioisotope inlet wherein the first radioisotope inlet is configured to enable a first portion of the purified radioisotope to flow into the focusing means in a first flow direction, the second radioisotope inlet is configured to enable a second portion of the purified radioisotope to flow into the focusing means in a second flow direction, the first flow direction facing the second flow direction, and the target precursor inlet is configured to enable the target precursor to be injected into the focusing means in a third flow direction having an angle greater than zero relative to the first flow direction and the second flow direction.