Fully Automated GMP-Compliant Synthesis of [18F]FE-PE2I
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Fully Automated GMP-Compliant Synthesis of [18F]FE-PE2I. / Bratteby, Klas; Denholt, Charlotte Lund; Lehel, Szabolcs; Petersen, Ida Nymann; Madsen, Jacob; Erlandsson, Maria; Ohlsson, Tomas; Herth, Matthias Manfred; Gillings, Nic.
I: Pharmaceuticals, Bind 14, Nr. 7, 601, 2021.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Fully Automated GMP-Compliant Synthesis of [18F]FE-PE2I
AU - Bratteby, Klas
AU - Denholt, Charlotte Lund
AU - Lehel, Szabolcs
AU - Petersen, Ida Nymann
AU - Madsen, Jacob
AU - Erlandsson, Maria
AU - Ohlsson, Tomas
AU - Herth, Matthias Manfred
AU - Gillings, Nic
PY - 2021
Y1 - 2021
N2 - In the struggle to understand and accurately diagnose Parkinson's disease, radiopharmaceuticals and medical imaging techniques have played a major role. By being able to image and quantify the dopamine transporter density, noninvasive diagnostic imaging has become the gold standard. In the shift from the first generation of SPECT tracers, the fluorine-18-labeled tracer [18F]FE-PE2I has emerged as the agent of choice for many physicians. However, implementing suitable synthesis for the production of [18F]FE-PE2I has proved more challenging than expected. Through a thorough analysis of the relevant factors affecting the final radiochemical yield, we were able to implement high-yielding fully automated GMP-compliant synthesis of [18F]FE-PE2I on a Synthera®+ platform. By reaching RCYs up to 62%, it allowed us to isolate 25 GBq of the formulated product, and an optimized formulation resulted in the shelf life of 6 h, satisfying the increased demand for this radiopharmaceutical.
AB - In the struggle to understand and accurately diagnose Parkinson's disease, radiopharmaceuticals and medical imaging techniques have played a major role. By being able to image and quantify the dopamine transporter density, noninvasive diagnostic imaging has become the gold standard. In the shift from the first generation of SPECT tracers, the fluorine-18-labeled tracer [18F]FE-PE2I has emerged as the agent of choice for many physicians. However, implementing suitable synthesis for the production of [18F]FE-PE2I has proved more challenging than expected. Through a thorough analysis of the relevant factors affecting the final radiochemical yield, we were able to implement high-yielding fully automated GMP-compliant synthesis of [18F]FE-PE2I on a Synthera®+ platform. By reaching RCYs up to 62%, it allowed us to isolate 25 GBq of the formulated product, and an optimized formulation resulted in the shelf life of 6 h, satisfying the increased demand for this radiopharmaceutical.
U2 - 10.3390/ph14070601
DO - 10.3390/ph14070601
M3 - Journal article
C2 - 34206688
VL - 14
JO - Pharmaceuticals
JF - Pharmaceuticals
SN - 1424-8247
IS - 7
M1 - 601
ER -
ID: 282314516