Quality comparability analysis on production site change of human coagulation factor Ⅷ
10.13303/j.cjbt.issn.1004-549x.2024.10.011
- VernacularTitle:人凝血因子Ⅷ生产场地变更的质量可比性分析
- Author:
Tianli TIAN
1
;
Hanyu WANG
;
Yiyun MA
;
Wei XUE
;
Shengchao ZHANG
;
Yaoyin ZHANG
;
Shunbo ZHOU
;
Lin-Gling ZOU
;
Chuan CHEN
;
Yaling DING
Author Information
1. 成都蓉生药业有限责任公司血浆检测部,四川成都 610000
- Keywords:
human coagulation factor Ⅷ(FⅧ);
site change;
quality indexes
- From:
Chinese Journal of Blood Transfusion
2024;37(10):1152-1157,1200
- CountryChina
- Language:Chinese
-
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 im-purities 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 resi-due,tributyl phosphate residue,polysorbate 80 residue and PEG residue all met the quality standard.Other impurities in-cluding 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.
