Low cost and open source purification apparatus for GMP [13N]Ammonia production

Farah Kamar; Michael S Kovacs; Justin W Hicks

doi:10.1016/j.apradiso.2022.110214

Low cost and open source purification apparatus for GMP [¹³N]Ammonia production

Appl Radiat Isot. 2022 Jul:185:110214. doi: 10.1016/j.apradiso.2022.110214. Epub 2022 Apr 4.

Authors

Farah Kamar¹, Michael S Kovacs², Justin W Hicks³

Affiliations

¹ Medical Biophysics, Western University, London, ON, Canada.
² Medical Biophysics, Western University, London, ON, Canada; Medical Imaging, Western University, London, ON, Canada; Cyclotron and Radiochemistry Facility, Lawson Health Research Institute, London, ON, Canada.
³ Medical Biophysics, Western University, London, ON, Canada; Cyclotron and Radiochemistry Facility, Lawson Health Research Institute, London, ON, Canada. Electronic address: jhicks@lawsonimaging.ca.

PMID: 35397362
DOI: 10.1016/j.apradiso.2022.110214

Abstract

Nitrogen-13 labeled ammonia ([¹³N]NH₃) has been used for myocardial perfusion imaging with Positron Emission Tomography for decades. Recent increases to regulatory oversight have led to stricter adherence to Good Manufacturing Practice (GMP) when producing this short half-life (9.97 min) radiopharmaceutical. This has increased production costs. Our cyclotron facility initially developed a manual GMP production method, but it was prone to human error. With increased costs in mind, we developed and validated an Arduino-based device to purifying [¹³N]NH₃ for clinical use. Construction, programming, and GMP validation results are discussed. The automated method was found to produce equivalent quality radiopharmaceutical but was more reproducible and robust.

Keywords: Automation; Good Manufacturing Practice; N-13 ammonia; Positron emission tomography; Radiopharmaceuticals.

MeSH terms

Ammonia*
Humans
Nitrogen Radioisotopes
Positron-Emission Tomography / methods
Radiopharmaceuticals*

Substances

Nitrogen Radioisotopes
Nitrogen-13
Radiopharmaceuticals
Ammonia