Differences in Domestic and International Supervision of Blood Products Virus Safety and Related Recommendations
10.3870/j.issn.1004-0781.2025.08.012
- VernacularTitle:血液制品病毒安全性国内外监管的差异及其建议
- Author:
Peng WU
1
;
Denis KLOCHKOV
;
Jens REHBEIN
;
Christoph ZUERCHER
;
Connie BROUMIS
;
Eleonora WIDMER
;
Wei ZHANG
;
Zhihua YUE
;
Zhigang ZHAO
Author Information
1. CSL Behring China(杰特贝林中国),上海 200031
- Publication Type:Journal Article
- Keywords:
Blood products;
Virus safety;
Quarantine period;
Virus removal/inactivation
- From:
Herald of Medicine
2025;44(8):1265-1271
- CountryChina
- Language:Chinese
-
Abstract:
Blood products are biological products derived from human plasma for use in clinical treatment.As such,they inherently carry the risk of blood-bome viral contamination,which has garnered significant attention from regulatory agencies worldwide regarding the viral safety of these products.This article compares and discusses the differences in domestic and international regulations on viral safety for blood products,focusing on aspects such as raw material selection and viral testing.Additionally,the article explores further impactful measures for viral safety control,namely,viral reduction during the manufacturing process and strategies to prevent cross-contamination.Moreover,we propose corresponding recommendations for China's regulatory framework to further enhance the viral safety of blood products in the country.
