YAN Chen, XIONG Keqiang, WANG Wenji, LI Ling. Inactivation and validation of virus in blood products of human coagulation factor Ⅷ[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
| Citation:
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YAN Chen, XIONG Keqiang, WANG Wenji, LI Ling. Inactivation and validation of virus in blood products of human coagulation factor Ⅷ[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
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Inactivation and validation of virus in blood products of human coagulation factor Ⅷ
- 1.
Shanghai Xinxing Medical Company Limited, Shanghai 200135, China
- 2.
Shanghai Colorcon Coating Technology Limited, Shanghai 201206, China
- Received Date: 2013-03-05
- Rev Recd Date:
2013-06-19
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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 Ⅷ extracted from healthy human plasma 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 Ⅷ experiments, 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 observed in the activation and other indicators of human coagulation factor Ⅷ.
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