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GMP-compliant automated radiosynthesis of [18F] SynVesT-1 for PET imaging of synaptic vesicle glycoprotein 2 A (SV2A).
Chen, Lijuan; Li, Xiaochen; Ge, Yao; Li, Huiqiang; Li, Ruili; Song, Xiaosheng; Liang, Jianfei; Zhang, Weifeng; Li, Xiaona; Wang, Xiaoqi; Wang, Yunjuan; Wu, Yaping; Bai, Yan; Wang, Meiyun.
Afiliación
  • Chen L; Department of Medical Imaging, Henan Provincial People's Hospital & the People's Hospital of Zhengzhou University, Zhengzhou, 450003, China.
  • Li X; Department of Medical Imaging, Henan Provincial People's Hospital & the People's Hospital of Zhengzhou University, Zhengzhou, 450003, China.
  • Ge Y; Department of Medical Imaging, Henan Provincial People's Hospital & the People's Hospital of Zhengzhou University, Zhengzhou, 450003, China.
  • Li H; Department of Medical Imaging, Henan Provincial People's Hospital & the People's Hospital of Zhengzhou University, Zhengzhou, 450003, China.
  • Li R; School of Clinical Medicine, Henan University, Kaifeng, 475004, China.
  • Song X; Institute of Biomedicine, Henan Academy of Sciences, Zhengzhou, 450046, China.
  • Liang J; Beijing PET CO., LTD, Beijing, 100093, China.
  • Zhang W; Department of Medical Imaging, Henan Provincial People's Hospital & the People's Hospital of Zhengzhou University, Zhengzhou, 450003, China.
  • Li X; Department of Medical Imaging, Henan Provincial People's Hospital & the People's Hospital of Zhengzhou University, Zhengzhou, 450003, China.
  • Wang X; School of Clinical Medicine, Henan University, Kaifeng, 475004, China.
  • Wang Y; Institute of Biomedicine, Henan Academy of Sciences, Zhengzhou, 450046, China.
  • Wu Y; School of life sciences, Henan University, Kaifeng, 475004, China.
  • Bai Y; Department of Medical Imaging, Henan Provincial People's Hospital & the People's Hospital of Zhengzhou University, Zhengzhou, 450003, China.
  • Wang M; Department of Medical Imaging, Henan Provincial People's Hospital & the People's Hospital of Zhengzhou University, Zhengzhou, 450003, China.
EJNMMI Radiopharm Chem ; 9(1): 66, 2024 Sep 10.
Article en En | MEDLINE | ID: mdl-39254802
ABSTRACT

BACKGROUND:

A novel positron emission tomography (PET) imaging tracer, [18F] SynVesT-1, targeting synaptic vesicle glycoprotein 2 (SV2A), has been developed to meet clinical demand. Utilizing the Trasis AllinOne-36 (AIO) module, we've automated synthesis to Good Manufacturing Practice (GMP) standards, ensuring sterile, pyrogen-free production. The fully GMP-compliant robust synthesis of [18F] SynVesT-1 boosting reliability and introducing a significant degree of simplicity and its comprehensive validation for routine human use.

RESULTS:

[18F] SynVesT-1 was synthesized by small modifications to the original [18F] SynVesT-1 synthesis protocol to better fit AIO module using an in-house designed cassette and sequence. With a relatively small precursor load of 5 mg, [18F] SynVesT-1 was obtained with consistently high radiochemical yields (RCY) of 20.6 ± 1.2% (the decay-corrected RCY, n = 3) at end of synthesis. Each of the final formulated batches demonstrated radiochemical purity (RCP) and enantiomeric purity surpassing 99%. The entire synthesis process was completed within a timeframe of 80 min (75 ± 3.1 min, n = 3), saves 11 min compared to reported GMP automated synthesis procedures. The in-human PET imaging of total body PET/CT and time-of-flight (TOF) PET/MR showed that [18F] SynVesT-1 is an excellent tracer for SV2A. It is advantageous for decentralized promotion and application in multi-center studies.

CONCLUSION:

The use of AIO synthesizer maintains high production yields and increases reliability, reduces production time and allows rapid training of production staff. Besides, the as-prepared [18F] SynVesT-1 displays excellent in vivo binding properties in humans and holds great potential for the imaging and quantification of synaptic density in vivo.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: EJNMMI Radiopharm Chem Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: EJNMMI Radiopharm Chem Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido