Standardization of fluorine-18 manufacturing processes: new scientific challenges for PET.

Autor: Hjelstuen OK; GE Healthcare, Medical Diagnostics R&D, Oslo, Norway. ole.hjelstuen@ge.com, Svadberg A, Olberg DE, Rosser M
Jazyk: angličtina
Zdroj: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2011 Aug; Vol. 78 (3), pp. 307-13. Date of Electronic Publication: 2011 Feb 04.
DOI: 10.1016/j.ejpb.2011.01.002
Abstrakt: In [(18)F]fluoride chemistry, the minute amounts of radioactivity taking part in a radiolabeling reaction are easily outnumbered by other reactants. Surface areas become comparably larger and more influential than in standard fluorine chemistry, while leachables, extractables, and other components that normally are considered small impurities can have a considerable influence on the efficiency of the reaction. A number of techniques exist to give sufficient (18)F-tracer for a study in a pre-clinical or clinical system, but the chemical and pharmaceutical understanding has significant gaps when it comes to scaling up or making the reaction more efficient. Automation and standardization of [(18)F]fluoride PET tracers is a prerequisite for reproducible manufacturing across multiple PET centers. So far, large-scale, multi-site manufacture has been established only for [(18)F]FDG, but several new tracers are emerging. In general terms, this transition from small- to large-scale production has disclosed several scientific challenges that need to be addressed. There are still areas of limited knowledge in the fundamental [(18)F]fluoride chemistry. The role of pharmaceutical factors that could influence the (18)F-radiosynthesis and the gaps in precise chemistry knowledge are discussed in this review based on a normal synthesis pattern.
(Copyright © 2011 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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