Establishment of the first international standard for PEGylated granulocyte colony stimulating factor (PEG-G-CSF): report of an international collaborative study.
Bottom Line: However, because of the variability in potency estimates seen when PEG-G-CSF preparations were compared with the current WHO 2nd IS for G-CSF, a candidate PEG-G-CSF was suitable as the WHO IS.The preparation 12/188 was judged suitable to serve as the WHO IS based on in vitro biological activity data.Therefore, the preparation coded 12/188 was established by the WHO Expert Committee on Biological Standardization (ECBS) in 2013 as the WHO 1st IS for human PEGylated G-CSF with an assigned in vitro bioactivity of 10,000IU per ampoule.
Affiliation: Biotherapeutics Group, NIBSC, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK. Electronic address: Meenu.Wadhwa@nibsc.org.Show MeSH
Mentions: These results clearly indicate that the candidate PEG-G-CSF preparation A, coded 12/188 can be used as a reference standard for in vitro bioactivity of PEGylated G-CSF preparations (that are manufactured to be representative of the approved product, INN PEG-Filgrastim). Dose response curves of different PEG-G-CSF products relative to the PEG-G-CSF reference standard are illustrated in Fig. 5. It was proposed to the WHO ECBS that the candidate preparation (sample A, coded 12/188) be established as the WHO 1st IS for in vitro bioactivity of PEG-G-CSF with an assigned value of 10,000 IU/ampoule for biological activity. This unitage is arbitrary and unrelated to the unitage for the current WHO 2nd IS for G-CSF.
Affiliation: Biotherapeutics Group, NIBSC, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK. Electronic address: Meenu.Wadhwa@nibsc.org.