title: Design of CGMP production of 18F- and 68Ga-radiopharmaceuticals.
abstract: OBJECTIVE
  Radiopharmaceutical production process must adhere to current good manufacturing process (CGMP) compliance to ensure the quality of precursor, prodrug (active pharmaceutical ingredient, API), and the final drug product that meet acceptance criteria. We aimed to develop an automated system for production of CGMP grade of PET radiopharmaceuticals.
  
  
  METHODS
  The hardware and software of the automated synthesizer that fit in the hot cell under cGMP requirement were developed. Examples of production yield and purity for (68)Ga-DOTATATE and (18)F-FDG at CGMP facility were optimized. Analytical assays and acceptance criteria for cGMP grade of (68)Ga-DOTATATE and (18)F-FDG were established.
  
  
  RESULTS
  CGMP facility for the production of PET radiopharmaceuticals has been established. Radio-TLC and HPLC analyses of (68)Ga-DOTATATE and (18)F-FDG showed that the radiochemical purity was 92% and 96%, respectively. The products were sterile and pyrogenic-free.
  
  
  CONCLUSIONS
  CGMP compliance of radiopharmaceuticals has been reviewed. (68)Ga-DOTATATE and (18)F-FDG were synthesized with high radiochemical yield under CGMP process.
authors.affiliation: PET Pharm Biotech Company Limited, 1-2F No. 143 and 1-2F No. 141 HouGang, Xinzhuang District, New Taipei City 24257, Taiwan.
authors.forename: Yen-Ting
authors.identifier: 0000-0002-7721-2007
authors.initials: YT
authors.lastname: Chi
authors.affiliation: PET Pharm Biotech Company Limited, 1-2F No. 143 and 1-2F No. 141 HouGang, Xinzhuang District, New Taipei City 24257, Taiwan.
authors.forename: Pei-Chun
authors.initials: PC
authors.lastname: Chu
authors.affiliation: PET Pharm Biotech Company Limited, 1-2F No. 143 and 1-2F No. 141 HouGang, Xinzhuang District, New Taipei City 24257, Taiwan.
authors.forename: Hao-Yu
authors.initials: HY
authors.lastname: Chao
authors.affiliation: PET Pharm Biotech Company Limited, 1-2F No. 143 and 1-2F No. 141 HouGang, Xinzhuang District, New Taipei City 24257, Taiwan.
authors.forename: Wei-Chen
authors.initials: WC
authors.lastname: Shieh
authors.affiliation: PET Pharm Biotech Company Limited, 1-2F No. 143 and 1-2F No. 141 HouGang, Xinzhuang District, New Taipei City 24257, Taiwan.
authors.forename: Chuck C
authors.initials: CC
authors.lastname: Chen
mesh_terms: D001331:Automation; D019788:Fluorodeoxyglucose F18 / Q000138:chemical synthesis*; D005710:Gallium Radioisotopes / Q000737:chemistry*; D006801:Humans; D049268:Positron-Emission Tomography; D011854:Radiochemistry / Q000379:methods*; D011874:Radiometry; D019275:Radiopharmaceuticals / Q000138:chemical synthesis*
chemical_list: D005710:Gallium Radioisotopes; D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18