Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals
AbstractRadiopharmaceuticals 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
Scifeed alert for new publicationsNever miss any articles matching your research from any publisher
- Get alerts for new papers matching your research
- Find out the new papers from selected authors
- Updated daily for 49'000+ journals and 6000+ publishers
- Define your Scifeed now
Ha, N.S.; Sadeghi, S.; van Dam, R.M. Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals. Micromachines 2017, 8, 337.
Ha NS, Sadeghi S, van Dam RM. Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals. Micromachines. 2017; 8(11):337.Chicago/Turabian Style
Ha, Noel S.; Sadeghi, Saman; van Dam, R. M. 2017. "Recent Progress toward Microfluidic Quality Control Testing of Radiopharmaceuticals." Micromachines 8, no. 11: 337.
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.