The 2nd International Standard for human granulocyte colony stimulating factor
| Autor: | Michelle Hamill, Paul Matejtschuk, Chris Bird, Meenu Wadhwa, Alan B Heath, Robin Thorpe |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
business.industry
International standard Immunology Reference Standards Pharmacology World Health Organization Expert committee Cell Line Granulocyte colony-stimulating factor Mice Human sequence Drug Stability Granulocyte Colony-Stimulating Factor Animals Humans Immunology and Allergy Bioassay Medicine business Reference standards |
| Zdroj: | Journal of Immunological Methods. 367:63-69 |
| ISSN: | 0022-1759 |
| DOI: | 10.1016/j.jim.2011.02.005 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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