Bioactivity Determination of a Therapeutic Recombinant Human Keratinocyte Growth Factor by a Validated Cell-based Bioassay
文献类型：期刊论文
| 作者 | Yao, Wenrong1,2; Guo, Ying1; Qin, Xi1; Yu, Lei1; Shi, Xinchang1; Liu, Lan1; Zhou, Yong1; Hu, Jinpan1; Rao, Chunming1; Wang, Junzhi1 |
| 刊名 | MOLECULES
 |
| 出版日期 | 2019-02-02 |
| 卷号 | 24期号:4页码:13 |
| 关键词 | rhKGF-1 rhKGF-2 bioactivity cell-based bioassay method validation |
| ISSN号 | 1420-3049 |
| DOI | 10.3390/molecules24040699 |
| 英文摘要 | The therapeutic recombinant human keratinocyte growth factor 1 (rhKGF-1) was approved by the FDA for oral mucositis resulting from hematopoietic stem cell transplantation for hematological malignancies in 2004. However, no recommended bioassay for rhKGF-1 bioactivity has been recorded in the U.S. Pharmacopoeia. In this study, we developed an rhKGF-1-dependent bioassay for determining rhKGF-1 bioactivity based on HEK293 and HaCat cell lines that stably expressed the luciferase reporter driven by the serum response element (SRE) and human fibroblast growth factor receptor (FGFR2) IIIb. A good responsiveness to rhKGF-1 and rhKGF-2 shared by target HEK293/HaCat cell lines was demonstrated. Our stringent validation was completely focused on specificity, linearity, accuracy, precision, and robustness according to the International Council for Harmonization (ICH) Q2 (R1) guidelines, AAPS/FDA Bioanalytical Workshop and the Chinese Pharmacopoeia. We confirmed the reliability of the method in determining rhKGF bioactivity. The validated method is highly timesaving, sensitive, and simple, and is especially valuable for providing information for quality control during the manufacture, research, and development of therapeutic rhKGF. |
| WOS关键词 | RECEPTOR SPECIFICITY ; EXPRESSION ; KINASE ; IMPLEMENTATION ; PROLIFERATION ; THERAPIES ; DOMAIN |
| 资助项目 | MOST of China[2018ZX09101001] ; MOST of China[2018S001] |
| WOS研究方向 | Biochemistry & Molecular Biology ; Chemistry |
| 语种 | 英语 |
| WOS记录号 | WOS:000460805900045 |
| 出版者 | MDPI |
| 资助机构 | MOST of China |
| 源URL | [http://ir.ipe.ac.cn/handle/122111/28342]  |
| 专题 | 中国科学院过程工程研究所 |
| 通讯作者 | Rao, Chunming; Wang, Junzhi |
| 作者单位 | 1.Natl Inst Food & Drug Control, 2 Tiantan Xili, Beijing 100050, Peoples R China 2.Chinese Acad Sci, Inst Proc Engn, 1 North 2nd St, Beijing 100190, Peoples R China |
| 推荐引用方式 GB/T 7714 | Yao, Wenrong,Guo, Ying,Qin, Xi,et al. Bioactivity Determination of a Therapeutic Recombinant Human Keratinocyte Growth Factor by a Validated Cell-based Bioassay[J]. MOLECULES,2019,24(4):13. |
| APA | Yao, Wenrong.,Guo, Ying.,Qin, Xi.,Yu, Lei.,Shi, Xinchang.,...&Wang, Junzhi.(2019).Bioactivity Determination of a Therapeutic Recombinant Human Keratinocyte Growth Factor by a Validated Cell-based Bioassay.MOLECULES,24(4),13. |
| MLA | Yao, Wenrong,et al."Bioactivity Determination of a Therapeutic Recombinant Human Keratinocyte Growth Factor by a Validated Cell-based Bioassay".MOLECULES 24.4(2019):13. |
入库方式： OAI收割
来源：过程工程研究所
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