A1 Refereed original research article in a scientific journal
Automated GMP production and long-term experience in radiosynthesis of CB(1)tracer [F-18]FMPEP-d(2)
Authors: Salla Lahdenpohja, Thomas Keller, Sarita Forsback, Tapio Viljanen, Esa Kokkomäki, Riikka V. Kivelä, Jörgen Bergman,Olof Solin, Anna K. Kirjavainen
Publisher: WILEY
Publication year: 2020
Journal: Journal of Labelled Compounds and Radiopharmaceuticals
Journal name in source: JOURNAL OF LABELLED COMPOUNDS & RADIOPHARMACEUTICALS
Journal acronym: J LABELLED COMPD RAD
Volume: 63
Issue: 9
First page : 408
Last page: 418
Number of pages: 11
ISSN: 0362-4803
eISSN: 1099-1344
DOI: https://doi.org/10.1002/jlcr.3845
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/48729106
Here, we describe the development of an in-house-built device for the fully automated multistep synthesis of the cannabinoid CB(1)receptor imaging tracer (3R,5R)-5-(3-([F-18]fluoromethoxy-d(2))phenyl)-3-(((R)-1-phenylethyl)amino)-1-(4-(trifluoromethyl)phenyl)pyrrolidin-2-one ([F-18]FMPEP-d(2)), following good manufacturing practices. The device is interfaced to a HPLC and a sterile filtration unit in a clean room hot cell. The synthesis involves the nucleophilic(18)F-fluorination of an alkylating agent and its GC purification, the subsequent(18)F-fluoroalkylation of a precursor molecule, the semipreparative HPLC purification of the(18)F-fluoroalkylated product, and its formulation for injection. We have optimized the duration and temperature of the(18)F-fluoroalkylation reaction and addressed the radiochemical stability of the formulated product. During the past 5 years (2013-2018), we have performed a total of 149 syntheses for clinical use with a 90% success rate. The activity yield of the formulated product has been 1.0 +/- 0.4 GBq starting from 11 +/- 2 GBq and the molar activity 600 +/- 300 GBq/mu mol at the end of synthesis.
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