title: Hemophilia therapy innovation: development of an advanced category recombinant factor VIII by a plasma/albumin-free method. Proceedings of a Special Symposium at the XIXth Congress of the International Society on Thrombosis and Haemostasis, July 12-18, 2003, Birmingham, UK.
abstract: Replacement therapy for hemophilia A has evolved from the early use of whole blood, citrated plasma, and cryoprecipitate, to purified factor VIII (FVIII) concentrates, first derived from plasma, then produced by recombinant DNA technology. Recombinant FVIII (rFVIII) concentrates have provided improved safety for patients with hemophilia A since they significantly reduce the risk of transmission of blood-borne infections. Nevertheless, human- or animal-derived plasma proteins are still included at some step in preparation of all previously licensed rFVIII, thereby introducing the potential for transmission of human or animal pathogens. Anti-hemophilic factor (recombinant), plasma/albumin-free method (rAHF-PFM), a novel advanced category rFVIII produced without the addition of human or animal plasma proteins, has been developed with the goal of providing the greatest possible margin of safety to hemophilia patients. This report, based on a symposium of the XIXth International Society on Thrombosis and Haemostasis Congress, provides an overview of the rAHF-PFM development program as well as current findings from the global clinical evaluation of rAHF-PFM in pediatric and adult previously treated patients.
authors.affiliation: Baxter Healthcare Corporation, Baxter Bioscience, Westlake Village, CA 91362, USA.
authors.forename: B M
authors.initials: BM
authors.lastname: Ewenstein
authors.forename: P
authors.initials: P
authors.lastname: Collins
authors.forename: M D
authors.initials: MD
authors.lastname: Tarantino
authors.forename: C
authors.initials: C
authors.lastname: Negrier
authors.forename: V
authors.initials: V
authors.lastname: Blanchette
authors.forename: A D
authors.initials: AD
authors.lastname: Shapiro
authors.forename: D
authors.initials: D
authors.lastname: Baker
authors.forename: G
authors.initials: G
authors.lastname: Spotts
authors.forename: M
authors.initials: M
authors.lastname: Sensel
authors.forename: S E
authors.initials: SE
authors.lastname: Yi
authors.forename: E D
authors.initials: ED
authors.lastname: Gomperts
mesh_terms: D000328:Adult; D000818:Animals; D002648:Child; D002986:Clinical Trials as Topic; D005069:Evaluation Studies as Topic; D005169:Factor VIII / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013502:General Surgery; D006467:Hemophilia A / Q000188:drug therapy*; D006801:Humans; D010949:Plasma; D011786:Quality Control; D011994:Recombinant Proteins / Q000009:adverse effects / Q000302:isolation & purification / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012709:Serum Albumin
chemical_list: D011994:Recombinant Proteins; D012709:Serum Albumin; D005169:Factor VIII