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Micromachines 2017, 8(11), 337; https://doi.org/10.3390/mi8110337

Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals

1
Department of Bioengineering, Henry Samueli School of Engineering and Applied Science, University of California Los Angeles, Los Angeles, CA 90095, USA
2
Crump Institute for Molecular Imaging and Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095, USA
*
Author to whom correspondence should be addressed.
Received: 27 September 2017 / Revised: 8 November 2017 / Accepted: 18 November 2017 / Published: 21 November 2017
(This article belongs to the Special Issue Integrated Microfluidics for Chemical Synthesis and Analysis)
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Abstract

Radiopharmaceuticals labeled with short-lived positron-emitting or gamma-emitting isotopes are injected into patients just prior to performing positron emission tomography (PET) or single photon emission tomography (SPECT) scans, respectively. These imaging modalities are widely used in clinical care, as well as in the development and evaluation of new therapies in clinical research. Prior to injection, these radiopharmaceuticals (tracers) must undergo quality control (QC) testing to ensure product purity, identity, and safety for human use. Quality tests can be broadly categorized as (i) pharmaceutical tests, needed to ensure molecular identity, physiological compatibility and that no microbiological, pyrogenic, chemical, or particulate contamination is present in the final preparation; and (ii) radioactive tests, needed to ensure proper dosing and that there are no radiochemical and radionuclidic impurities that could interfere with the biodistribution or imaging. Performing the required QC tests is cumbersome and time-consuming, and requires an array of expensive analytical chemistry equipment and significant dedicated lab space. Calibrations, day of use tests, and documentation create an additional burden. Furthermore, in contrast to ordinary pharmaceuticals, each batch of short-lived radiopharmaceuticals must be manufactured and tested within a short period of time to avoid significant losses due to radioactive decay. To meet these challenges, several efforts are underway to develop integrated QC testing instruments that automatically perform and document all of the required tests. More recently, microfluidic quality control systems have been gaining increasing attention due to vastly reduced sample and reagent consumption, shorter analysis times, higher detection sensitivity, increased multiplexing, and reduced instrumentation size. In this review, we describe each of the required QC tests and conventional testing methods, followed by a discussion of efforts to directly miniaturize the test or examples in the literature that could be implemented for miniaturized QC testing. View Full-Text
Keywords: radiopharmaceuticals; pharmaceuticals; microfluidics; quality control (QC) testing; positron emission tomography (PET); single photon emission computed tomography (SPECT); lab-on-a-chip; sensor radiopharmaceuticals; pharmaceuticals; microfluidics; quality control (QC) testing; positron emission tomography (PET); single photon emission computed tomography (SPECT); lab-on-a-chip; sensor
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
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Ha, N.S.; Sadeghi, S.; van Dam, R.M. Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals. Micromachines 2017, 8, 337.

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