A process for solvent/detergent treatment of plasma for transfusion at blood centers that use a disposable-bag system

Thierry Burnouf, Hadi Alphonse Goubran, Miryana Radosevich, Makram A. Sayed, George Gorgy, Magdy El-Ekiaby

Research output: Contribution to journalArticle

32 Citations (Scopus)

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 α2-antiplasmin. Two S/D treatment procedures for single donations or minipools of plasma have been developed with a single-use bag system. STUDY DESIGN AND METHODS: Frozen plasma samples were thawed and treated in disposable bags with either 2 percent tri(n-butyl)phosphate (TnBP) at 37°C or 1 percent TnBP and 1 percent Triton X-45 at 31°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°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, α2-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. CONCLUSION: 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.

Original languageEnglish
Pages (from-to)2100-2108
Number of pages9
JournalTransfusion
Volume46
Issue number12
DOIs
Publication statusPublished - Dec 2006
Externally publishedYes

Fingerprint

Blood Transfusion
Detergents
Octoxynol
Therapeutics
Antifibrinolytic Agents
Protein S
Castor Oil
Technology
Blood Coagulation Factors
Antithrombins
Protein C
Protease Inhibitors
Centrifugation
Anticoagulants
Fibrinogen
Immunoglobulins
Blood Proteins
Albumins
tributyl phosphate
Viruses

ASJC Scopus subject areas

  • Hematology
  • Immunology

Cite this

A process for solvent/detergent treatment of plasma for transfusion at blood centers that use a disposable-bag system. / Burnouf, Thierry; Goubran, Hadi Alphonse; Radosevich, Miryana; Sayed, Makram A.; Gorgy, George; El-Ekiaby, Magdy.

In: Transfusion, Vol. 46, No. 12, 12.2006, p. 2100-2108.

Research output: Contribution to journalArticle

Burnouf, Thierry ; Goubran, Hadi Alphonse ; Radosevich, Miryana ; Sayed, Makram A. ; Gorgy, George ; El-Ekiaby, Magdy. / A process for solvent/detergent treatment of plasma for transfusion at blood centers that use a disposable-bag system. In: Transfusion. 2006 ; Vol. 46, No. 12. pp. 2100-2108.
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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 α2-antiplasmin. Two S/D treatment procedures for single donations or minipools of plasma have been developed with a single-use bag system. STUDY DESIGN AND METHODS: Frozen plasma samples were thawed and treated in disposable bags with either 2 percent tri(n-butyl)phosphate (TnBP) at 37°C or 1 percent TnBP and 1 percent Triton X-45 at 31°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°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, α2-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. CONCLUSION: 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.",
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AU - Burnouf, Thierry

AU - Goubran, Hadi Alphonse

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AU - Sayed, Makram A.

AU - Gorgy, George

AU - El-Ekiaby, Magdy

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AB - 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 α2-antiplasmin. Two S/D treatment procedures for single donations or minipools of plasma have been developed with a single-use bag system. STUDY DESIGN AND METHODS: Frozen plasma samples were thawed and treated in disposable bags with either 2 percent tri(n-butyl)phosphate (TnBP) at 37°C or 1 percent TnBP and 1 percent Triton X-45 at 31°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°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, α2-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. CONCLUSION: 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.

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