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. CONCLUSION:CGMP compliance of radiopharmaceuticals has been reviewed. (68)Ga-DOTATATE and (18)F-FDG were synthesized with high radiochemical yield under CGMP process.
journal_name
Biomed Res Intjournal_title
BioMed research internationalauthors
Chi YT,Chu PC,Chao HY,Shieh WC,Chen CCdoi
10.1155/2014/680195subject
Has Abstractpub_date
2014-01-01 00:00:00pages
680195eissn
2314-6133issn
2314-6141journal_volume
2014pub_type
杂志文章abstract::Macrophages play a key role in immunity. In this review, we consider the traditional notion of macrophage plasticity, data that do not fit into existing concepts, and a hypothesis for existence of a new switch macrophage phenotype. Depending on the microenvironment, macrophages can reprogram their phenotype toward the...
journal_title:BioMed research international
pub_type: 杂志文章,评审
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journal_title:BioMed research international
pub_type: 杂志文章
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journal_title:BioMed research international
pub_type: 杂志文章,随机对照试验
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journal_title:BioMed research international
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journal_title:BioMed research international
pub_type: 杂志文章,评审
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journal_title:BioMed research international
pub_type: 临床试验,杂志文章
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更新日期:2013-01-01 00:00:00
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pub_type: 临床试验,杂志文章
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pub_type: 杂志文章,评审
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pub_type: 杂志文章
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journal_title:BioMed research international
pub_type: 杂志文章
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