用于GMP [N]氨生产的低成本开源纯化设备。
Low cost and open source purification apparatus for GMP [N]Ammonia production.
作者信息
Kamar Farah, Kovacs Michael S, Hicks Justin W
机构信息
Medical Biophysics, Western University, London, ON, Canada.
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.
出版信息
Appl Radiat Isot. 2022 Jul;185:110214. doi: 10.1016/j.apradiso.2022.110214. Epub 2022 Apr 4.
Nitrogen-13 labeled ammonia ([N]NH) 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 [N]NH 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.
几十年来，氮-13标记的氨（[N]NH）一直用于正电子发射断层扫描的心肌灌注成像。最近监管监督的加强导致在生产这种半衰期短（9.97分钟）的放射性药物时，要更严格地遵守药品生产质量管理规范（GMP）。这增加了生产成本。我们的回旋加速器设施最初开发了一种手动GMP生产方法，但它容易出现人为错误。考虑到成本增加，我们开发并验证了一种基于 Arduino 的设备，用于纯化临床使用的 [N]NH。本文讨论了该设备的构造、编程和GMP验证结果。结果发现，这种自动化方法能生产出质量相当的放射性药物，而且更具可重复性和稳定性。
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