Augmented solvent/detergent method for inactivating enveloped and non-enveloped viruses
Patent 6881573 Issued on April 19, 2005. Estimated Expiration Date: September 12, 2023. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
435/320.1, VECTOR, PER SE (E.G., PLASMID, HYBRID PLASMID, COSMID, VIRAL VECTOR, BACTERIOPHAGE VECTOR, ETC.) BACTERIOPHAGE VECTOR, ETC.)435/69.1, Recombinant DNA technique included in method of making a protein or polypeptide435/6, Involving nucleic acid530/350, PROTEINS, I.E., MORE THAN 100 AMINO ACID RESIDUES424/147.1Binds virus or component thereof
A process for making Solvent Detergent (SD) treatment effective against non-enveloped viruses. The process stipulates using prequalified concentrations of formaldehyde and phenol with SD treatments. In particular, serial or combined use of 100 to 10,000 parts per million of formaldehyde and/or 100 to 10,000 parts per million of phenol with an associated SD treatment process are disclosed.
Other References
Ager, A.; Anderson, SL; Louderback AL; Milhous, WK; Formaldehyde/Detergent Solution Prevents Blood Borne Transmission of [Plasmaodium] Infection in a Mouse Model, American Society of Tropical Medicine and Hygiene, Abstract Submission Form, Annual Meeting, 1991.
Ehud Ben-Hur, Bernard Horowitz, Virus Inactivation in Blood, Editorial Review, AIDS 1996, 10:1183-1190, Rapid Science Publishers ISSN 0269-9370.
Chen, SX; Hammond, DJ; Lang, JM; Lebing, WR; Purification of α1 Protinase Inhibitor from Human Plasma Fraction IV-1 by Ion Exchange Chromatography; Vox Sanguinis, 1998: 74(4): 232-241.
Chen, SX; Hammond, DJ; Klos, AM; Wood, DW; Wydick, JE; Lebing, WR; Chromatography Purification of human α1 Proteinase Inhibitor from Dissolved Cohn Fraction IV-1 Paste; Journal of Chromatography A. 800 (2) (1998): 207-218.
Highsmith, F; Xue, H; Chen, X; Benade, L; Owens, J; Shanbrom, E; Drohan, W; Iodine-mediated Inactivation of Lipid- and Nonlipid-enveloped Viruses in Human Antithrombin III Concentrate; Blood, vol. 86, No. 2, (Jul. 18, 1995); pp. 791-798.
Highsmith, FA; Xue, H; Caple, M; Walthall, B; Drohan, WN, Shanbrom, E; Inactivation of Lipid-Enveloped and Non-lipid-enveloped Model Viruses in Normal Human Plasma by Crosslinked Starch-iodine: Plasma Derivatives Department, Holland Laboratory, American Red Cross, Rockville, Maryland, and Irvine Scientific Incorporated, Santa Ana, California; received for publication Aug. 26, 1993, revised No. 16, 1993 and accepted Nov. 22, 1993; published in Transfusion, 1994; vol. 34, No. 4, pp. 322-327.
Highsmith, FA; Caple, M; Walthall, B; Shanbrom, E; Drohan, WN; Viral Inactivation of Vasicular Stomatitis Virus in Normal Human Serum by Cross-Linked Polyvinylpyrrolidone; The Journal of Infectious Diseases, 1993;167:1027-33, published by The University of Chicago.
Horowitz, B; Prince, AM; Hamman, J; Watklevicz,C; Viral Safety of Solvent/Detergent-treated Blood Products; Blood Coagul. Fibrinolysis. 1994 Dec; 5 Suppl 3: S21-28. See Abstract for safety of S/D products; p. S22 for viral safety in formal clinical trials and Tables 1 and 2.
Horowitz, B; Pathogen Inactivated Transfusion Plasma: Existing and Emerging Methods, a proceedings paper from Vox Sanguinis (Vox Sang 2002: 83, (Suppl. 1): 429-436.
Horowitz, B; Ben-Hur, E; Efforts in Minimizing Risk of Viral Transmission through Viral Inactivation; The Finish Medical Society Duodecim, Ann. Med. 2000, 32: 475-484.
Horowitz, B; Lazo, A; Grossberg, H; Page, G; Lippin, A; Swan, G.; Virus Inactivation by Solvent/Detergent Treatment and the Manufacture of SD-Plasma; Vox Sanguinis, Lunch Symposium Paper; Vox Sang. 1998, 74 Suppl. 1;: 203-206.
Horowitz, B; Prince, AM; Hamman, J; Watklevicz, C; Viral Safety of Solvent/Detergent-treated blood products—Abstract; Dev Biol Stand. 1993;81: 147-161.
Korneyeya, M; Hottta, J; Lebing, W; Rosenthal, RS; Franks, L; Petteway, SR Jr.; Enveloped Virus Inactivation by Caprylate: a Robust Alternative to Solvent-Detergent Treatment in Plasma Derived Intermediates; Biologicals, Jun. 2002; 30(2): 153-62.
Lebing, WR; Hammond, DJ; Wydick, JE III, Baumbach, GA; A Highly Purified Antithrombin III Concentrate Prepared from Human Plasma Fraction IV-1 by Affinity Chromatography; Vox Sanguinis , Vox Sang., 1994; 67(2): 117-124.
Lebing, W; Remington, KM; Schreiner, C; Paul, I; Properties of a New Intravenous Immunoglobulin (IGIV-C, 10%) Produced by Virus Inactivation with Caprylate and Column Chromatography; copyright Blackwell Publishing, Ltd., Vox Sanguinis (2003): 84(3), 193-201.
Lee, DC; Stenland, CJ; Miller JLC; Cai, K; Ford, EK; Gilligan, KJ; Hartwell, RC; Terry, JC; Rubenstein, R; Fournel, M; Petteway SR Jr.; A Direct Relationship between the Partioning of the Pathogenic Prion Protein and Transmissible Spongiform Encephalopathy Infectivity during the Purification of Plasma Proteins; Transfusion, 2001: 41(4): 449-455.
Louderback, A; A Protocol for Sterilization of Blood for Transfusion; Oral presentation at the 5th National Forum on AIDS, Hepatitis and other Blood Borne Diseases; CDC Meeting, Atlanta, GA on Mar. 30, 1992.
Louderback, A; Sterilization of Red Blood Cells for Transfusion; Speech at 45th AABB Meeting in San Francisco, Nov. 11, 1992 .
Miller. JLC; Petteway, SR Jr; Lee, DC; Ensuring the Pathogen Safety of Intravenous Immunoglobulin and Other Human Plasma-derived Therapeutic Proteins; Journal of Allergy Clinical Immunology, Oct. 2001 V. 108, pp. S91-4 (Figure S92).
Robinson, S; Schwinn, H; Josic, D; Nur, I; Stradler, M; Bal, F; Gehringer, W; Schutz, R; Development and Biochemical Characterization of a Double-virus-inactivated Factor VIII Preparation, Blood Coagulation and Fibrinolysis, Vol. 6, Suppl. 2, 1995, copyrighted by Rapid Science Publishers; pp. S40-47.
Schwinn, H; Stadler, M; Josic, DJ; Bal, F; Gehringer, W; Nur, I: Schūtz, R; A Solvent 1 Detergent Treated, Pasteurised and Highly Purified Factor VIII Concentrate; Arzneim.-Forsch./Drug Res. 44(1) , Nr. 2 (1994) pp. 188-191 (English and German).
Stenland, CJ; Lee, DC; Brown, P; Petteway SR Jr.; Rubenstein, R; Partitioning of Human and Sheep Forms of the Pathogenic Prion during the Purification of Therapeutic Proteins from Human Plasma, Transfusion, vol. 42(11), Nov. 2002, pp. 1497-1500.
Trejo, SR; Hotta, JA; Lebing, W; Stenland, C; Storms, RE; Lee, DC; Petteway, LS Jr.; Remington, KM; Evaluation of Virus and Prion Reduction in a New Intravenous Immunoglobulin Manufacturing Process; Vox Sanguinis (2003) 84, 176-187, copyrighted by Blackwell Publishing, Ltd.
Cai, K; Miller, JL; Stenland, CJ; Gilligan, KJ; Hartwell, RC; Terry, JC; Evans-Storms, RB; Rubenstein, R; Peteway, SR Jr.; Lee, DC; Solvent-dependent Precipitation of Prion Protein. Biochimica et Biophysica Acta. May 20, 2002; 1597(1): 28-35, See Abstract plus p. 32 (Figure 4) and p. 33 (Figures 5 and 6).
September 12, 2023. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
