CAS OpenIR
Bioactivity Determination of a Therapeutic Recombinant Human Keratinocyte Growth Factor by a Validated Cell-based Bioassay
Yao, Wenrong1,2; Guo, Ying1; Qin, Xi1; Yu, Lei1; Shi, Xinchang1; Liu, Lan1; Zhou, Yong1; Hu, Jinpan1; Rao, Chunming1; Wang, Junzhi1
2019-02-02
Source PublicationMOLECULES
ISSN1420-3049
Volume24Issue:4Pages:13
Abstract

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.

KeywordRhkgf-1 Rhkgf-2 Bioactivity Cell-based Bioassay Method Validation
DOI10.3390/molecules24040699
Language英语
WOS KeywordReceptor Specificity ; Expression ; Kinase ; Implementation ; Proliferation ; Therapies ; Domain
Funding ProjectMOST of China[2018ZX09101001] ; MOST of China[2018S001]
WOS Research AreaBiochemistry & Molecular Biology ; Chemistry
WOS SubjectBiochemistry & Molecular Biology ; Chemistry, Multidisciplinary
Funding OrganizationMOST of China
WOS IDWOS:000460805900045
PublisherMDPI
Citation statistics
Document Type期刊论文
Identifierhttp://ir.ipe.ac.cn/handle/122111/28342
Collection中国科学院过程工程研究所
Corresponding AuthorRao, Chunming; Wang, Junzhi
Affiliation1.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
Recommended Citation
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.
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