Virus Inactivation by Solvent/Detergent Treatment and the Manufacture of SD-Plasma
| Autor: | Bernard Horowitz, G. Page, A. Lazo, H. Grossberg, G. Swan, A Lippin |
|---|---|
| Rok vydání: | 1998 |
| Předmět: |
Virus inactivation
medicine.drug_class Detergents Safety margin Monoclonal antibody law.invention Plasma Viral envelope law Blood-Borne Pathogens Humans Medicine Solvent detergent Plasma Exchange business.industry Sterilization Hematology General Medicine Virology Retroviridae Virus Diseases Plasma products Solvents Recombinant DNA Fresh frozen plasma business |
| Zdroj: | Vox Sanguinis. 74:203-206 |
| ISSN: | 0042-9007 |
| DOI: | 10.1111/j.1423-0410.1998.tb05473.x |
| Popis: | Solvent/Detergent (SD) is an extraordinarily effective means for eliminating enveloped viruses from plasma and plasma products. The safety margin suggested by the rapid and complete kill of enveloped viruses observed in the laboratory has been confirmed repeatedly by groups worldwide and by thirteen years of routine clinical use encompassing an estimated 35 million doses of a wide variety of products. Throughout this time, there has not been a single documented case of enveloped virus transmission by an SD-treated product. This record of safety spawned the development of SD-treated plasma as a substitute for fresh frozen plasma (FFP) and has encouraged the adoption of SD for the treatment of non-blood products such as monoclonal antibodies and those derived from recombinant DNA procedures. This review summarizes the use of SD treatment, including its use in combination with other viral elimination procedures, and also summarizes Vitex's initial experience in the manufacture of SD-Plasma, recently licensed by the U.S. FDA. |
| Databáze: | OpenAIRE |
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