title: A process for solvent/detergent treatment of plasma for transfusion at blood centers that use a disposable-bag system.
abstract: BACKGROUND
  Solvent/detergent (S/D) inactivates enveloped viruses in plasma. The current technology requires a plasma fractionation facility and is applied to large plasma pools, which increases the cost and risks of exposure to S/D-resistant pathogens and lowers the content of protein S and alpha2-antiplasmin. Two S/D treatment procedures for single donations or minipools of plasma have been developed with a single-use bag system.
  
  
  METHODS
  Frozen plasma samples were thawed and treated in disposable bags with either 2 percent tri(n-butyl)phosphate (TnBP) at 37 degrees C or 1 percent TnBP and 1 percent Triton X-45 at 31 degrees C for 4 hours. Plasma samples were extracted three times with 7.5 percent sterile castor oil to remove TnBP and Triton X-45. The TnBP-treated plasma samples were further subjected to a clarifying centrifugation (3800 x g, 30 min). Final plasma samples were dispensed into individual bags and frozen at -30 degrees C. Plasma quality was assessed at each step of the procedures.
  
  
  RESULTS
  Both processes yielded greater than 90 percent mean recovery of coagulation factors (clottable fibrinogen, von Willebrand factor, and factors VIII, V, VII, IX, X, and XI), anticoagulants (protein C, protein S), protease inhibitors (antithrombin, alpha2-antiplasmin), total protein, albumin, and immunoglobulins. Global coagulation tests of the treated plasma samples were normal. Final TnBP and Triton X-45 content was less than 10 and 50 ppm, respectively.
  
  
  CONCLUSIONS
  S/D treatment of plasma can be performed in a closed-bag system under conditions that maintain plasma protein quality. The technology is simple, presents advantages over the industrial large-scale S/D plasma process, and could be performed in blood centers.
authors.affiliation: Human Plasma Product Services, Lille, France. tburnou@attglobal.net
authors.forename: Thierry
authors.initials: T
authors.lastname: Burnouf
authors.forename: Hadi Alphonse
authors.initials: HA
authors.lastname: Goubran
authors.forename: Miryana
authors.initials: M
authors.lastname: Radosevich
authors.forename: Makram A
authors.initials: MA
authors.lastname: Sayed
authors.forename: George
authors.initials: G
authors.lastname: Gorgy
authors.forename: Magdy
authors.initials: M
authors.lastname: El-Ekiaby
mesh_terms: D001771:Blood Banks; D001793:Blood Preservation / Q000379:methods*; D001798:Blood Proteins / Q000032:analysis; D001803:Blood Transfusion; D006801:Humans; D017830:Octoxynol / Q000494:pharmacology*; D010755:Organophosphates / Q000494:pharmacology*; D014777:Virus Diseases / Q000517:prevention & control; D038301:Virus Inactivation / Q000187:drug effects*
chemical_list: D001798:Blood Proteins; D010755:Organophosphates; D017830:Octoxynol; C009524:tributyl phosphate