Solvent/Detergent-Treated Plasma: A Virus-Inactivated Substitute for Fresh Frozen Plasma

• Published in: Blood Vol. 79; no. 3; pp. 826 - 831
• Main Authors: Horowitz, Bernard, Bonomo, Richard, Prince, Alfred M., Chin, Sing N., Brotman, Betsy, Shulman, Richard W.
• Format: Journal Article
• Language: English
• Published: Washington, DC Elsevier Inc 01.02.1992; The Americain Society of Hematology
• Subjects: AIDS/HIV; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Animals; Biological and medical sciences; Blood Coagulation Factors - chemistry; Blood Proteins - immunology; Blood Proteins - ultrastructure; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis; Detergents - chemistry; Hepacivirus - drug effects; Hepatitis B virus - drug effects; HIV - drug effects; Humans; Immunoelectrophoresis, Two-Dimensional; Medical sciences; Organophosphates - chemistry; Pan troglodytes; Plasma - chemistry; Plasma - microbiology; Polyethylene Glycols - chemistry; Polysorbates - chemistry; Sindbis Virus - drug effects; Solvents - chemistry; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Vesicular stomatitis Indiana virus - drug effects; Human; Virus; Detergent; Treatment; Conservation; Fresh blood; Disinfection; Technique; Solvent; Freezing; Blood plasma
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V79.3.826.826

Fresh frozen plasma (FFP) is prepared in blood banks world-wide as a by-product of red blood cell concentrate preparation. Appropriate clinical use is for coagulation factor disorders where appropriate concentrates are unavailable and when multiple coagulation factor deficits occur such as in surgery. Viral safety depends on donor selection and screening; thus, there continues to be a small but defined risk of viral transmission comparable with that exhibited by whole blood. We have prepared a virus sterilized FFP (S/D-FFP) by treatment of FFP with 1% tri(n-butyl)phosphate (TNBP) and 1% Triton X-100 at 30°C for 4 hours. Added reagents are removed by extraction with soybean oil and chromatography on insolubilized C18 resin. Treatment results in the rapid and complete inactivation of ≥ 107.5 infectious doses (ID50) of vesicular stomatitis virus (VSV) and ≥ 106.9 ID50 of sindbis virus (used as marker viruses), ≥ 106.2ID50 of human immunodeficiency virus (HIV), ≥ 106 chimp infectious doses (CID50) of hepatitis B virus (HBV), and ≥ 105 CID50 of hepatitis C virus (HCV). Immunization of rabbits with S/D-FFP and subsequent adsorption of elicited antibodies with untreated FFP confirmed the absence of neoimmungen formation. Coagulation factor content was comparable with that found in FFP. Based on these laboratory and animal studies, together with the extensive history of the successful use of S/D-treated coagulation factor concentrates, we conclude that replacement of FFP with S/D-FFP, prepared in a manufacturing facility, will result in improved virus safety and product uniformity with no loss of efficacy.© 1992 by The American Society of Hematology. 0006-4971/92/7903-0032$3.00/0