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Removal and Inactivation of Hepatitis B Virus from Contaminated Pooled Plasma in a Large‐Scale Manufacturing Process for Factor VIII and Human Serum Albumin
Author(s) -
Murozuka T.,
Aoki M.,
Kimura N.,
Sotoyama K.,
Abe I.,
Izumi H.,
Emura H.,
Takeda Y.,
Nanakawa H.,
Katsubayashi Y.,
Takeuchi T.,
Ito H.,
Hirakawa S.,
Mitsunaga S.,
Tadokoro K.,
Kanemitsu K.,
Miyamoto M.,
Yamanaka R.,
Nishioka K.
Publication year - 1999
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1046/j.1423-0410.1999.7630181.x
Subject(s) - hbsag , hepatitis b virus , albumin , antibody , human albumin , virology , affinity chromatography , virus , chemistry , contamination , hepatitis c virus , human serum albumin , hepatitis b , chromatography , medicine , biology , biochemistry , immunology , enzyme , ecology
Background and Objectives:The Japanese Red Cross Society recalled one lot of monoclonal‐antibody‐purified factor VIII (F VIII) and two lots of human serum albumin (HSA) 5 months after preparation of the final products, because of a procedural error that led to contamination by a unit of plasma positve for hepatitis B surface antigen (HBsAg). We evaluated the effectiveness of virus inactivation/removal in a large‐scale process for manufacturing F VIII and HSA. Materials and Methods: HBV DNA in the retained samples in process was measured by the polymerase chain reaction (PCR). The kinetics of virus inactivation by solvent‐detergent (S/D) treatment was examined using model viruses. We also did a look‐back survey of the patients who received corresponding products. Results: Contaminated hepatitis B virus (HBV) DNA became undetectable beyond fraction S IV‐I in the albumin process, and immunoaffinity chromatography in the F VIII process, respectively. The model viruses were inactivated within 5 s by S/D treatment. There is no evidence that patients were infected by HBV after transfusion of these products. Conclusion: We conclude that virus inactivation/removal was effectively achieved in a large‐scale manufacturing process for F VIII and HSA.