Solvent/detergent treatment of human plasma -: A very robust method for virus inactivation.: Validated virus safety of OCTAPLAS®

被引：52

作者：

Blesert, L

Suhartono, H

机构：

[1] Chemotherapeut Forschungsinst, Frankfurt, Germany

[2] Octapharma AG, Ziegelbrucke, Switzerland

来源：

VOX SANGUINIS | 1998年 / 74卷

关键词：

human plasma; fresh frozen; plasma; process limitation; solvent/detergent; virus safety; virus validation;

D O I：

10.1111/j.1423-0410.1998.tb05474.x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OCTAPLAS(R) is a cell-free standardized blood group specific human coagulation active plasma fbr transfusion. The viral safety is mainly based on the treatment with solvent/detergent. SD is known to irreversibly inactivate the lipid enveloped viruses including HIV 1+2, HBV and HCV and has been recommended both by European guidelines and the FDA. The potential limitation of each inactivation method should be validated according to the current EU-guidelines CPMP/BWP/268/95 and CPMP/BWP/269/95. Our studies demonstrate that the SD method inactivates Lipid enveloped viruses within a few minutes to below the limit of detection. The concentration of the SD reagents as well as several other process parameters chosen for the virus inactivation step of plasma pools of different protein and lipid composition result in a high safety margin towards the clinically relevant viruses.

引用

页码：207 / 212

页数：6

共 11 条

[1]

BIESERT L, 1995, INFUSIONSTHERAPIE, V22, P2

[2]

BIESERT L, 1996, CLIN EXP RHEUMATOL, V14, P47

[3] INACTIVATION OF VIRUSES IN LABILE BLOOD DERIVATIVES .1. DISRUPTION OF LIPID-ENVELOPED VIRUSES BY TRI( NORMAL-BUTYL)PHOSPHATE DETERGENT COMBINATIONS [J].