System for radiopharmaceutical production
AssigneeUniversity of Hull
InventorsStephen James Archibald, Ping He, Nathan Joel Brown, Mark Duncan Tarn, Stephen John Haswell, Mohammad Mehdi Nasr Esfahani, Nicole Pamme, Richard Alexander
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Abstract
Certain embodiments of the present invention relate to a system and a method for producing a radiopharmaceutical, wherein the system is formed from and/or provides a microfluidic flow system. In certain embodiments, the system comprises a radioisotope isolation module, a radiopharmaceutical production module, a purification module and a quality control module.
Claims31
A microfluidic system for the production of a radiopharmaceutical composition comprising:
- a Radioisotope Isolation Module (RIM) configured to receive an aqueous solution comprising a radioisotope;
- a Radiopharmaceutical Production Module (RPM) configured to receive a first sample which comprises a concentrated and activated radioisotope from the RIM;
- a Purification Module (PM) configured to receive a second sample which comprises a radiopharmaceutical and one or more further components from the RPM;
- and
- a Quality Control Module (QCM), configured to receive a third sample from the PM which comprises a purified radiopharmaceutical and which is further configured to determine one or more characteristics of the third sample;
- wherein:
- the RIM, RPM, PM and QCM are provided as an integrated system on a single microfluidic chip;
- the RIM, RPM, PM and QCM are each independently a microfluidic component of the integrated system having at least one channel for fluid flow of less than 500 μm;
- and
- the PM and the QCM each independently comprise a chromatographic inorganic monolithic body that is a cation exchange, anion exchange, normal phase, or reverse phase monolithic body comprising functionalized silica.
A method of producing a radiopharmaceutical composition comprising:
- a) supplying an aqueous solution comprising a radioisotope to a Radioisotope Isolation Module (RIM) and forming a first sample comprising a concentrated and activated radioisotope;
- b) supplying the first sample from the RIM to a Radiopharmaceutical Production Module (RPM);
- c) supplying a second sample which comprises a radiopharmaceutical or an intermediate and optionally one or more further components to a Purification Module (PM) configured to receive the second sample from the RPM;
- d) supplying a third sample which comprises a purified radiopharmaceutical from the PM to a Quality Control Module (QCM);
- and
- e) performing at least one analytical technique on the third sample or a portion thereof to determine at least one characteristic of the third sample;
- wherein:
- the RIM, RPM, PM and QCM are provided as an integrated system on a single microfluidic chip;
- the RIM, RPM, PM and QCM are each independently a microfluidic component of the integrated system having at least one channel for fluid flow of less than 500 μm;
- and
- the PM and QCM each independently comprise a chromatographic inorganic monolithic body that is a cation exchange, anion exchange, normal phase, or reverse phase monolithic body comprising functionalized silica.
Dependencies are inferred from the claim text.