title: The 2nd International Standard for human granulocyte colony stimulating factor.
abstract: Five candidate preparations of human sequence recombinant granulocyte-colony stimulating factor (G-CSF) were formulated and lyophilized at NIBSC prior to evaluation in a collaborative study for their suitability to serve as a replacement International Standard (IS). The preparations were tested by 13 laboratories using in vitro bioassays. The candidate preparation 09/136 was judged suitable to serve as a replacement international standard based on the data obtained for biological activity and stability. On the basis of the results reported here, the preparation coded 09/136 was established by the WHO Expert Committee on Biological Standardization (ECBS) as the 2nd IS for human G-CSF with an assigned value for G-CSF activity of 95,000 IU/ampoule. Calibration of the 2nd IS is primarily based on the bioassay in use in various laboratories and relies entirely on the estimates calculated relative to the WHO 1st IS for continuity of the IU.
authors.affiliation: Biotherapeutics Group, NIBSC, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK. Meenu.Wadhwa@nibsc.hpa.org.uk
authors.forename: Meenu
authors.initials: M
authors.lastname: Wadhwa
authors.forename: Chris
authors.initials: C
authors.lastname: Bird
authors.forename: Michelle
authors.initials: M
authors.lastname: Hamill
authors.forename: Alan B
authors.initials: AB
authors.lastname: Heath
authors.forename: Paul
authors.initials: P
authors.lastname: Matejtschuk
authors.forename: Robin
authors.initials: R
authors.lastname: Thorpe
mesh_terms: D000818:Animals; D002460:Cell Line; D004355:Drug Stability; D016179:Granulocyte Colony-Stimulating Factor / Q000494:pharmacology / Q000592:standards*; D006801:Humans; D051379:Mice; D012015:Reference Standards; D014944:World Health Organization
chemical_list: D016179:Granulocyte Colony-Stimulating Factor