A two‐center study for the quality control of [18F]FDG using FASTlab phosphate cassettes

Abstract

The US (USP), British (BP), European (EP) and Japanese (JP) pharmacopeias demand that [(18)F]FDG for injection should be clear and particulate free within the given shelf-life/expiration time. To avoid Al-phosphate precipitation within the product expiry time, FASTlab citrate cassettes, rather than phosphate cassettes, should be used for [(18)F]FDG production. Although testing for Al(3+) is not listed in the [(18)F]FDG monographs of the USP, BP and EP, residual Al(3+) levels should be considered in the interests of patient safety.

Development of an automated, GMP compliant FASTlab™ radiosynthesis of [18F]GE‐179 for the clinical study of activated NMDA receptors

“…The FASTlab™ synthesiser was developed by GE Healthcare for the automated production of [ 18 F]fluorine radiotracers. The synthesiser was designed to aid PET radiopharmaceutical manufacturers to comply with the GMP requirements for PET radiopharmaceuticals . The disposable, single‐use cassette, removes the need to validate a cleaning protocol as the disposable fluid path removes any potential for cross contamination between productions.…”

“…The synthesiser was designed to aid PET radiopharmaceutical manufacturers to comply with the GMP requirements for PET radiopharmaceuticals. [22][23][24][25][26][27][28][29][30][31][32] The disposable, single-use cassette, removes the need to validate a cleaning protocol as the disposable fluid path removes any potential for cross contamination between productions.…”

18F-labelling innovations and their potential for clinical application

“…For example, the [ 18 F]FDG cassettes for the most used synthesis devices, namely the GE FASTlab, are available with phosphate or citrate buffer. In a two-centre study it was found out that the phosphate cassettes often show precipitates of aluminium phosphates, formed by the interaction of phosphate buffer with Al 3+ ions eluted from the alumina cartridge, what does not fulfil the requirement of the Japanese Pharmacopeia and also not the requirements for product solution appearance of the other pharmacopoeias [248]. Noteworthy is also the great effort invested to prove the absence of crypt-222 in the final solution of 18 F-radiopharmaceuticals, which is another important quality control criterion.…”

Stability evaluation of [18F]FDG: literature study, stability studies from two different PET centres and future recommendations

“…A two-centre study investigated the use of phosphate buffer in GE Healthcare’s FASTlab synthesis cassettes module. It found that phosphate buffered reagent kits formed precipitation due to aluminium phosphate and thus did not recommend the use of phosphate buffered reagent kits even though another study found them to give the same radiochemical yield (Huang et al 2016 ; Long et al 2013 ). The main stability issue is radiation-related radiolysis of the active substance and solvents (Jószai et al 2019 ; Buriova et al 2005 ).…”