Quality comparability analysis on production site change of human coagulation factor Ⅷ

Abstract

Objective To study the quality comparability of human coagulation factor Ⅷ (FⅧ) produced before and after the change of factory site. Methods A comparative study was carried out on quality quantitative indexes, related impurities and stability data of FⅧ produced before and after the change of factory site. Results The FⅧ quantitative quality before and after the change of factory site all met the quality standard, and the related impurities including aluminum residue, tributyl phosphate residue, polysorbate 80 residue and PEG residue all met the quality standard. Other impurities including human fibrinogen, fibronectin, plasminogen, IgA, IgM and IgG were extremely low in content and equivalent in quality. The content of VWF (von Willebrand factor) had no obvious change before and after the change of factory site, but was significantly higher than that of other domestic manufacturers’ commercial products. The results of accelerated stability and long-term stability tests showed that the titer of FⅧ fluctuated within the methodological error range, and the results all met the quality standard. Conclusion The change of factory site of FⅧ has no effect on the quality.

Keywords

• human coagulation factor ⅷ(fⅷ)
• site change
• quality indexes