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: Intra-laboratory variability for in-house standards relative to samples A, B and C is summarised in Table 6. Slope ratios from individual plates are shown in Fig. 4. Bioassays performed on the first day by laboratory 21 are not shown as the slope ratios were < 0.30 in all bioassays on this day.
Affiliation: Biotherapeutics Group, NIBSC, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK. Electronic address: Meenu.Wadhwa@nibsc.org.