The World Health Organization reference reagent for keratinocyte growth factor, KGF.
Preparations of human sequence recombinant keratinocyte growth factor (KGF), fibroblast growth factor-7 (FGF-7) synthesized in E. coli were formulated and lyophilized at National Institute for Biological Standards and Control (NIBSC) and evaluated in a collaborative study using in vitro bioassays and immunoassays. One candidate standard was the full-length mature KGF molecule and the two others were different formulations of a truncated form of the molecule, KGF (24-163). The study demonstrated the difficulty of performing interlaboratory comparison of assays without a common reference standard and differences in dose-response relationships between molecular variants. On the basis of the results reported here, the World Health Organization (WHO) established the preparation coded 03/150 as the WHO reference reagent for human KGF, with an assigned unitage of 4000 units of KGF per ampoule and the preparation coded 03/148 as the WHO reference reagent for human KGF (24-163), with an assigned unitage of 9000 units of KGF(24-163) per ampoule.
Robinson
C Jane
CJ
National Institute for Biological Standards and Control, Herts EN6 3QG, UK. jrobinson@nibsc.ac.uk
Das
Rose Gaines
RG
Maile
Pauline
P
D001681:Biological Assay; D002460:Cell Line; D004305:Dose-Response Relationship, Drug; D051523:Fibroblast Growth Factor 7 / Q000032:analysis / Q000302:isolation & purification / Q000592:standards*; D006801:Humans; D011994:Recombinant Proteins / Q000302:isolation & purification / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results; D013696:Temperature; D014944:World Health Organization
D011994:Recombinant Proteins; D051523:Fibroblast Growth Factor 7