6 Recombinant clotting factor concentrates

Addiego, 1993, Frequency of inhibitor development in haemophiliacs treated with low purity factor VIII, Lancet, 342, 462, 10.1016/0140-6736(93)91593-B Antonarakis, 1995, Molecular etiology of factor VIII deficiency in hemophilia A, Human Mutation, 5, 1, 10.1002/humu.1380050102 Arkin, 1995, Kogenate: a recombinant technology derived human antihemophilic factor (FVIII) concentrate Berntorp, 1995, Deletion of the B-domain in a recombinant factor VIII (r-VIII SQ) does not affect the main kinetic properties—three pharmacokinetic studies in 36 patients with severe hemophilia A, Thrombosis and Haemostasis, 73, 1014 Boedeker, 1992, The manufacturing of recombinant factor VIII, Kogenate, Transfusion Medicine Reviews, 6, 256, 10.1016/S0887-7963(92)70177-1 Bray, 1992, Current status of clinical studies of recombinant factor VIII (Recombinate™) in patients with hemophilia A, Transfusion Medicine Reviews, 6, 252, 10.1016/S0887-7963(92)70176-X Bray, 1994, A multicenter study of recombinant factor VIII (Recombinate): safety, efficacy, and inhibitor risk in previously untreated patients with hemophilia A, Blood, 83, 2428 Bray, 1995, Results from the recombinate™ (recombinant factor VIII) study of previously untreated patients with hemophilia A: a 4.5 year follow-up report, Thrombosis and Haemostasis, 73, 1013 Chan, 1991, Genetic characterization of recombinant BHK-21 cells expressing factor VIII, Seminars in Hematology, 28, 10 Choo, 1982, Molecular cloning of the gene for human anti-hemophilic factor IX, Nature, 299, 178, 10.1038/299178a0 Eaton, 1986, Construction and characterization of an active factor VIII variant lacking the central one-third of the molecule, Biochemistry, 25, 8343, 10.1021/bi00374a001 Ehrenforth, 1992, Incidence of development of factor VIII and factor IX inhibitors in haemophiliacs, Lancet, 339, 594, 10.1016/0140-6736(92)90874-3 Fijnvandraat, 1996 Fournel, 1991, Preclinical and in vitro studies of recombinant factor VIII, Seminars in Hematology, 28, 22 Gitschier, 1994, Characterization of the human factor VIII gene, Nature, 312, 326, 10.1038/312326a0 Gomperts, 1992, The manufacturing process of recombinant factor VIII, Recombinate, Transfusion Medicine Reviews, 6, 247, 10.1016/S0887-7963(92)70175-8 Gruppo, 1995, Transient inhibitors in recipients or recombinant Factor VIII: a report from the Recombinate study of previously untreated patients, Blood, 86, 193a Hagen, 1986, Characterization of a rDNA coding for human factor VIII, 83, 2412 Hedner, 1992, Management of hemophilia patients with inhibitors, Hematology-Oncology Clinics of North America, 6, 1035, 10.1016/S0889-8588(18)30292-2 Hedner, 1988, Successful use of recombinant factor VIIa in patients with severe hemophilia A during synovectomy, Lancet, ii, 1193, 10.1016/S0140-6736(88)90259-0 Hedner, 1989, Clinical experience with human plasma-derived factor VIIa in patients with hemophilia A and high titer inhibitors, Haemostasis, 19, 335 Hedner, 1993, Recombinant activated factor VII in the treatment of bleeding episodes in patients with inherited and acquired bleeding disorders, Transfusion Medicine Reviews, 7, 78, 10.1016/S0887-7963(93)70126-1 Kane, 1987, Cloning of cDNAs coding for the heavy chain region and connecting region of human factor V, a blood coagulation factor with four types of repeats, Biochemistry, 26, 6508, 10.1021/bi00394a033 Kaufman, 1992, Expression and structure-function properties of recombinant factor VIII, Transfusion Medicine Reviews, 6, 235, 10.1016/S0887-7963(92)70174-6 Kaufman, 1994, Structure, biology, and genetics of factor VIII, 1633 Kaufman, 1986, Expression, purification, and characterization of recombinant gammacarboxylated factor IX synthesized in Chinese hamster ovary cells, Journal of Biological Chemistry, 261, 9622, 10.1016/S0021-9258(18)67559-3 Kaufman, 1988, Synthesis, processing and secretion of recombinant human factor VIII expressed in mammalian cells, Journal of Biological Chemistry, 263, 6352, 10.1016/S0021-9258(18)68793-9 Keith, 1995, Evaluation of recombinant human factor IX: pharmacokinetic studies in the rat and dog, Thrombosis and Haemostasis, 73, 101, 10.1055/s-0038-1653732 Klein, 1991, Production and characterization of recombinant factor VIII, Seminars in Hematology, 28, 17 Kurachi, 1982, Isolation and characterization of a cDNA encoding for human factor IX, 79, 6461 Lind, 1995, Novel forms of B-domain deleted recombinant factor VIII molecules, European Journal of Biochemistry, 10.1111/j.1432-1033.1995.tb20776.x Lindley, 1994, Pharmacokinetics and pharmacodynamics of recombinant factor VIIa, Clinical Pharmacology and Therapeutics, 55, 638, 10.1038/clpt.1994.80 Lusher, 1993, Recombinant factor VIII for the treatment of previously untreated patients with hemophilia A, New England Journal of Medicine, 328, 453, 10.1056/NEJM199302183280701 Lusher, 1994, Viral contamination of blood products, Lancet, 344, 405, 10.1016/S0140-6736(94)91430-3 Lusher, 1995, Recombinant FVIII (Kogenate) treatment of previously untreated patients (PUPs) with hemophilia A: update of safety, efficacy and inhibitor development after 5.8 study years, Thrombosis and Haemostasis, 76, 1012 Lusher, 1996, Recombinant factor VIIa (Novo Seven) in the treatment of internal bleeding in patients with factor VIII and factor IX inhibitors MacPherson, 1962, Polyoma transformation of hamster cell clones—an investigation of genetic factors affecting cell competence, Virology, 16, 147, 10.1016/0042-6822(62)90290-8 Mikaelsson, 1995, Manufacturing and characterization of a new B-domain deleted recombinant factor VIII, r-VIII SQ, Thrombosis and Haemostasis, 69, 1205 Ragni, 1995, Use of recombinant factor IX in three patients with hemophilia B undergoing surgery, Blood, 86, 194a Sandberg, 1994, A study of the function of a recombinant factor VIII protein with a deleted B-domain, r-VIII SQ, 106 Schmidt, 1994, Recombinant activated factor VII (rFVIIa) therapy for intracranial hemorrhage in hemophilia A patients with inhibitors, American Journal of Hematology, 47, 36, 10.1002/ajh.2830470108 Schulman, 1992, A therapeutic alternative for haemophiliacs with inhibitors, Acta Paediatrica, 81, 564, 10.1111/j.1651-2227.1992.tb12297.x Schwartz, 1990, Human recombinant DNA-derived anti-hemophilic factor (factor VIII) in the treatment of hemophilia A, New England Journal of Medicine, 323, 1800, 10.1056/NEJM199012273232604 Smeds, 1995, The purification process for recombinant factor VIII SQ, Thrombosis and Haemostasis, 73, 1013 Toole, 1984, Molecular cloning of a cDNA encoding human anti-hemophilic factor, Nature, 312, 342, 10.1038/312342a0 Toole, 1986, A large region (=95 kDa) of human factor VIII is dispensable for in vitro procoagulant activity, 83, 5939 Tuddenham, 1995, Purified factor VIII. Theoretical advantages, but at a cost?, British Medical Journal, 311, 465, 10.1136/bmj.311.7003.465 Vehar, 1984, Structure of human factor VIII, Nature, 312, 337, 10.1038/312337a0 White, 1989, Use of recombinant anti-hemophilic factor in the treatment of two patients with classical hemophilia, New England Journal of Medicine, 320, 166, 10.1056/NEJM198901193200307 White, 1995, A pharmacokinetic evaluation of recombinant human factor IX (rhFIX) in patients with severe hemophilia B, Thrombosis and Haemostasis, 73, 1014 Wood, 1984, Expression of active human factor VIII from recombinant DNA clones, Nature, 312, 342, 10.1038/312330a0