Changes of Main Functional Components of Human Plasma-derived Factor Ⅷ Products in China in Recent Years

doi:10.3969/j.issn.1671-2587.2025.03.013

JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE ›› 2025, Vol. 27 ›› Issue (3): 360-367.DOI: 10.3969/j.issn.1671-2587.2025.03.013

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Changes of Main Functional Components of Human Plasma-derived Factor Ⅷ Products in China in Recent Years

ZHAO Han¹, PEI Renjun^1,2, WANG Caixian¹, DU Xi¹, LI Xiaoyue¹, JIANG Peng¹, LIN Fangzhao¹, SUN Pan¹, CAO Haijun¹

¹Institute of Blood Transfusion, Chinese Academy of Medical Sciences & Peking Union Medical College, Chengdu 610052;
²Sir Run Run Shaw Hospital Affiliated with the Zhejiang University School of Medicine

Received:2024-12-23 Published:2025-06-23

Abstract

Abstract: Objective The changes in the main functional components of human plasma-derived factor Ⅷ (FⅧ)products in China in recent years were analyzed to provide a reference for the development of plasma protein products, improvement of the preparation processes of plasma-derived FⅧ, and their clinical application. Methods Nine commercially available FⅧ products (A-I) from Chinese manufacturers were dissolved according to the instructions. Protein concentration was measured using the BCA method, FⅧ activity was determined by a one-stage method, VWF activity and VWF antigen were assessed by immunoturbidimetry. The specific activity of FⅧ, the ratio of VWF:Ac/FⅧ:C and VWF:Ac/VWF:Ag were calculated and compared with products produced between 2015 and 2017 (a-g). The changes of main functional components of FⅧ were analyzed. Results The average FⅧ activity of product A-I was (20.70±2.06) IU/mL, showing no significant difference compared to previous products. The mean specific activity was (36.53±19.20) IU/mg, significantly higher than before (P<0.01). The average VWF:Ac/FⅧ:C was 0.43±0.12, indicating a significant decrease compared to previous products (P<0.000 1). The mean VWF:Ac/VWF:Ag was 0.70±0.16, also significantly lower than before (P<0.01). Compared with foreign product Wilate®, Chinese products exhibited significantly lower FⅧ specific activity (P<0.05) and VWF activity (P<0.000 1). Conclusion Currently, the purity of human plasma-derived FⅧ products in China exceeds the requirements of the Chinese Pharmacopoeia (2020 edition), and has significantly improved compared to the past. However, the quality of VWF activity has decreased making these products less suitable for treating von Willebrand disease (VWD). Compared with foreign products, human plasma-derived FⅧ products in China have a greater improvement in both FⅧ purity and VWF activity.

Key words: Human coagulation factor Ⅷ concentrates products, Von Willebrand factor, Von Willebrand disease, Human coagulation factor Ⅷ, Hemophilia A

CLC Number:

R977.8R331.1

ZHAO Han, PEI Renjun, WANG Caixian, DU Xi, LI Xiaoyue, JIANG Peng, LIN Fangzhao, SUN Pan, CAO Haijun. Changes of Main Functional Components of Human Plasma-derived Factor Ⅷ Products in China in Recent Years[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2025, 27(3): 360-367.

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Changes of Main Functional Components of Human Plasma-derived Factor Ⅷ Products in China in Recent Years

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