Large-scale production and properties of human plasma-derived activated Factor VII concentrate

Vox Sanguinis

Volumn 84, Issue 1, 2003, Pages 54-64

  Tomokiyo, Kazuhiko ^a   Yano, H ^a   Imamura, M ^a   Nakano, Y ^a   Nakagaki, T ^a   Ogata, Y ^a   Terano, T ^a   Miyamoto, S ^a   Funatsu, A ^a  

^a Chemo Sero Therapeutic Research Institute   (Japan)

Author keywords

Autoactivation; Factor VIIa; Factor VIIa ; Factor VII ; Gla domainless Factor VIIa; Plasma product

Indexed keywords

ANION EXCHANGE RESIN; BLOOD CLOTTING FACTOR 7A; BLOOD CLOTTING FACTOR 7A CONCENTRATE; CALCIUM ION; CITRIC ACID; GLYCINE; HUMAN ALBUMIN; MONOCLONAL ANTIBODY; UNCLASSIFIED DRUG;

ANION EXCHANGE CHROMATOGRAPHY; ARTICLE; CRYOPRECIPITATE; DEVICE; DIALYSIS; ENZYME ACTIVITY; FREEZE DRYING; HEATING; HEMOPHILIA; HUMAN; IMMUNOAFFINITY CHROMATOGRAPHY; NANOFILTRATION; PASTEURIZATION; PH; PLASMA; PRIORITY JOURNAL; PROTEIN DEGRADATION; PROTEIN PURIFICATION; SAFETY; TREATMENT INDICATION; VIRUS INACTIVATION;

BLOOD COMPONENT TRANSFUSION; CHROMATOGRAPHY, AFFINITY; CONSUMER PRODUCT SAFETY; FACTOR VIIA; FREEZE DRYING; HEAT; HUMANS; ION EXCHANGE RESINS; STERILIZATION; ULTRAFILTRATION; VIRUSES;

EID: 0037991119     PISSN: 00429007     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1423-0410.2003.00247.x     Document Type: Article

References (27)

1. Sjamsoedin LJ, Heijnen L, Mauser-Bunschoten EP, van Geijlswijk JL, van Houwelingen H, van Asten P, Sixma JJ: The effect of activated prothrombin-complex concentrate (FEIBA) on joint and muscle bleeding in patients with hemophilia A and antibodies to factor VIII. A double-blind clinical trial. N Engl J Med 1981; 305:717-721
2. Lusher JM, Blatt PM, Penner JA, Aledort LM, Levine PH, White GC, Warrier AI, Whitehurst DA: Autoplex versus proplex: A controlled, double-blind study of effectiveness in acute hemarthroses in hemophiliacs with inhibitors to factor VIII. Blood 1983; 62:1135-1138
3. Fukui H, Fujimura Y, Takahashi Y, Mikami S, Yoshioka A: Laboratory evidence of DIC under FEIBA treatment of a hemophilic patient with intracranial bleeding and high titre factor VIII inhibitor. Thromb Res 1981; 22:177-184
4. Mizon P, Goudemand J, Jude B, Marey A: Myocardial infarction after FEIBA therapy in a hemophilia-B patient with a factor IX inhibitor. Ann Hematol 1992; 64:309-311
5. Lusher JM, Roberts HR, Davignon G, Joist JH, Smith H, Shapiro A, Laurian Y, Kasper CK, Mannucci PM: A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. rFVIIa Study Group. Haemophilia 1998; 4:790-798
6. Hedner U: Recombinant activated factor VII as a universal haemostatic agent. Blood Coagul Fibrinolysis 1998; 9:S147-S152
7. Monroe DM, Hoffman M, Oliver JA, Roberts HR: A possible mechanism of action of activated factor VII independent of tissue factor. Blood Coagul Fibrinolysis 1998; 9:S15-S20
8. Hedner U, Bjoern S, Bernvil SS, Tengborn L, Stigendahl L: Clinical experience with human plasma-derived factor VIIa in patients with hemophilia A and high titer inhibitors. Haemostasis 1989; 19:335-343
9. Imamura M, Hata M, Nomura K, Nakagaki T, Mimaki I, Terano T, Funatsu A: Characterization of freeze-dried human activated coagulation factor VII concentrate (MC-7). Clin Report 1996; 30:315-326
10. Tomokiyo K, Teshima K, Nakatomi Y, Watanabe T, Mizuguchi J, Nozaki C, Nakagaki T, Miyamoto S, Funatsu A, Iwanaga S: Induction of acquired factor IX inhibitors in cynomolgus monkey (Macaca fascicularis): A new primate model of hemophilia B. Thromb Res 2001; 102:363-374
11. Bjoern S, Thim L: Activation of coagulation factor VII to VIIa. Res Disclosure 1986; 269:564-565
12. Pedersen AH, Lund-Hansen T, Bisgaard-Frantzen H, Olsen F, Petersen LC: Autoactivation of human recombinant coagulation factor VII. Biochemistry 1989; 28:9331-9336
13. Neuenschwander PF, Morrissey JH: Deletion of the membrane anchoring region of tissue factor abolishes autoactivation of factor VII but not cofactor function. Analysis of a mutant with a selective deficiency in activity. J Biol Chem 1992; 267:14477-14482
14. Sugo T, Mizuguchi J, Kamikubo Y, Matsuda M: Anti-human factor IX monoclonal antibodies specific for calcium ion-induced conformations. Thromb Res 1990; 58:603-614
15. March SC, Parikh I, Cuatrecasas P: A simplified method for cyanogen bromide activation of agarose for affinity chromatography. Anal Biochem 1974; 60:149-152
16. Orthner CL, Ralston AH, Gee D, Kent R, Kolen B, McGriff JD, Drohan WN: Large-scale production and properties of immunoaffinity-purified human activated protein C concentrate. Vox Sang 1995; 69:309-318
17. Laemmli UK: Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature 1970; 227:680-685
18. Koito A, Shirono K, Suto H, Matsushita S, Hattori T, Takatsuki K: Evaluation of the safety of blood products with respect to human immunodeficiency virus infection by using an HTLV-I-infected cell line (SKT-1B). Jpn J Cancer Res 1987; 78:365-371
19. Bharadwaj D, Harris RJ, Kisiel W, Smith KJ: Enzymatic removal of sialic acid from human factor IX and factor X has no effect on their coagulant activity. J Biol Chem 1995; 270:6537-6542
20. Warren L: The thiobarbituric acid assay of sialic acids. J Biol Chem 1959; 234:1971-1975
21. O'Hara PJ, Grant FJ, Haldeman BA, Gray CL, Insley MY, Hagen FS, Murray MJ: Nucleotide sequence of the gene coding for human factor VII, a vitamin K-dependent protein participating in blood coagulation. Proc Natl Acad Sci USA 1987; 84:5158-5162
22. Thim L, Bjoern S, Christensen M, Nicolaisen EM, Lund-Hansen T, Pedersen AH, Hedner U: Amino acid sequence and posttranslational modifications of human factor VIIa from plasma and transfected baby hamster kidney cells. Biochemistry 1988; 27:7785-7793
23. Broze GJ Jr, Majerus PW: Purification and properties of human coagulation factor VII. J Biol Chem 1980; 255:1242-1247
24. Bajaj SP, Rapaport SI, Brown SF: Isolation and characterization of human factor VII. Activation of factor VII by factor Xa. J Biol Chem 1981; 256:253-259
25. Sakai T, Lund-Hansen T, Thim L, Kisiel W: The γ-carboxyglutamic acid domain of human factor VIIa is essential for its interaction with cell surface tissue factor. J Biol Chem 1990; 265:1890-1894
26. Nicolaisen EM, Thim L, Jacobsen JK, Nielsen PF, Mollerup I, Jorgensen T, Hedner U: FVIIa derivatives obtained by autolytic and controlled cathepsin G mediated cleavage. FEBS Lett 1993; 317:245-249
27. Wakamatsu C, Takakura F, Kojima E, Kiriyama Y, Goto N, Matsumoto K, Oyama M, Sato H, Okochi K, Maeda Y: Screening of blood donors for human parvovirus B19 and characterization of the results. Vox Sang 1999; 76:14-21