Inactivation and validation of virus in blood products of human coagulation fac-torⅧ

VernacularTitle:人凝血因子Ⅷ血液制品中的病毒灭活与验证
Author: Chen YAN ¹ ; Keqiang XIONG ; Wenji WANG ; Ling LI
Author Information

1. 上海新兴医药股份有限公司
Keywords: human coagulation factor Ⅷ; virus inactivation; solvent/detergent treatment; dry heating
From: Journal of Pharmaceutical Practice 2014;(3):199-202
CountryChina
Language:Chinese
Abstract: Objective To study effect of virus inactivation/removal treated by solvent/detergent method and dry heating at 80℃, 72 h for inactivation in human coagulation factor Ⅷ.Methods Human coagulation factor Ⅷextracted from healthy human plas-ma were treated by solvent/detergent method and dry heating at 80℃, 72 h for inactivation .The virus inactivation effect was validated by adding the indicator virus ( PRV, Sindbis, HIV, EMCV, PPV).Results The methods could effectively inactivate lipid-enveloped and non lipid-enveloped viruses which could be used for virus inactivation /removal during human coagulation factor Ⅷexperiments , the residual amount of TNBP in production was less than one percent ten thousand (10 ppm), the residual Tween-80 concentration was less than one percent hundred thousand (100 ppm),which all met the safety standards .Conclusion and no significant change was ob-served in the activation and other indicators of human coagulation factor Ⅷ.