18F和68Ga放射性药物的CGMP生产设计。
Design of CGMP production of 18F- and 68Ga-radiopharmaceuticals.
作者信息
Chi Yen-Ting, Chu Pei-Chun, Chao Hao-Yu, Shieh Wei-Chen, Chen Chuck C
机构信息
PET Pharm Biotech Company Limited, 1-2F No. 143 and 1-2F No. 141 HouGang, Xinzhuang District, New Taipei City 24257, Taiwan.
出版信息
Biomed Res Int. 2014;2014:680195. doi: 10.1155/2014/680195. Epub 2014 Sep 2.
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.
CONCLUSION
CGMP compliance of radiopharmaceuticals has been reviewed. (68)Ga-DOTATATE and (18)F-FDG were synthesized with high radiochemical yield under CGMP process.
目的
放射性药物生产过程必须遵守现行药品生产质量管理规范（CGMP），以确保前体、前体药物（活性药物成分，API）及最终药品的质量符合验收标准。我们旨在开发一种用于生产CGMP级PET放射性药物的自动化系统。
方法
开发了符合cGMP要求且能置于热室中的自动化合成仪的硬件和软件。优化了CGMP设施中（68）Ga-DOTATATE和（18）F-FDG的生产产率和纯度示例。建立了CGMP级（68）Ga-DOTATATE和（18）F-FDG的分析方法和验收标准。
结果
已建立用于生产PET放射性药物的CGMP设施。对（68）Ga-DOTATATE和（18）F-FDG的放射性TLC和HPLC分析表明，其放射化学纯度分别为92%和96%。产品无菌且无热原。
结论
已对放射性药物的CGMP合规性进行了审查。在CGMP工艺下，（68）Ga-DOTATATE和（18）F-FDG以高放射化学产率合成。
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