[Solvent-detergent viral inactivation of minipools of plasma for transfusion, cryoprecipitate and cryo-poor plasma in single-use bag systems].
Non-virally inactivated plasma, cryoprecipitate and cryoprecipitate-poor plasma, prepared by blood establishments, are still used in many countries in the world, in both the developing world and industrialized countries, for the treatment of various hematological disorders. In the absence of viral inactivation treatment, these fractions may be involved, in spite of increasingly sensitive viral detection methods, into the transmission of plasma-borne viruses, most critically HIV and Hepatitis B (HBV) or C (HCV). We have adapted the well-established industrial solvent-detergent (SD) viral inactivation treatment to allow its application in a small scale using a single-use plastic bag system. The procedure can be used by blood establishments, without the need to build an industrial-scale manufacturing facility. Results show a good recovery of the functional activity of plasma proteins, including coagulation factors (such as factor VIII and coagulable fibrinogen) and/or protease inhibitors (such as alpha 2-antiplasmin). Viral validation studies revealed reduction factors greater than 4.17, greater than 4.73 and greater than 4.72 for HIV, BVDV and PRV, respectively, within a few minutes of treatment. A single-use SD treatment and SD-elimination system is currently under development to allow standardized use of the procedure by blood establishments or national or regional service centers.
Human Protein Process Sciences, Research and Development, 18, rue Saint-Jacques, 59000 Lille, France. tburnou@attglobal.net
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Burnouf
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Goubran
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Radosevich
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El-Ekiaby
D001793:Blood Preservation; D001798:Blood Proteins / Q000032:analysis; D001803:Blood Transfusion / Q000295:instrumentation* / Q000379:methods / Q000592:standards; D011232:Chemical Precipitation; D015925:Cryopreservation; D003902:Detergents / Q000494:pharmacology*; D006801:Humans; D010949:Plasma / Q000821:virology*; D011785:Quality Assurance, Health Care; D012997:Solvents / Q000494:pharmacology*; D054928:Validation Studies as Topic; D038301:Virus Inactivation / Q000187:drug effects*
D001798:Blood Proteins; D003902:Detergents; D012997:Solvents