Marianne Mikaelsson

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A new high-purity recombinant factor VIII preparation has been developed for the treatment of hemophilia A. Structurally, this factor VIII preparation, B-domain deleted recombinant factor VIII (BDDrFVIII), differs from other recombinant and plasma-derived factor VIII preparations in that most of the B-domain has been deleted. To ensure that BDDrFVIII(More)
Purpose. To investigate the influence of various nonreducing disaccharides and sugar alcohols on the inactivation kinetics of recombinant factor VIII SQ (r-VIII SQ) in aqueous solution not containing albumin as a stabiliser. Methods. The stability of r-VIII SQ was followed using measurement of activity (VIII: C) and HPLC gel filtration at different(More)
A second-generation recombinant factor VIII molecule was developed with an albumin-free formulation. In this modified form of factor VIII, the N- and C-terminal sections of the B-domain are retained and fused at serine 743 and glutamine 1638, resulting in a B-domain deleted factor VIII protein known as ReFacto (Genetics Institute, Andover, MA). Preclinical(More)
The factor VIII activity of B-domain deleted recombinant factor VIII (BDDrFVIII) measured by activated partial thromboplastin time (APTT)-based one-stage assays is approximately 50% of the activity obtained by the chromogenic assay. Similar results have been reported for the two licensed full-length recombinant factor VIII products. In view of these(More)
Purpose. To develop a stable freeze-dried formulation of recombinant factor VIII-SQ (r-VIII SQ) without the addition of albumin. Methods. Different formulations were evaluated for their protective effect during sterile filtration, freeze-thawing, freeze-drying, reconstitution and long term storage. Factor VIII activity (VIII:C), visual inspection, clarity,(More)
Human fraction I-0 (AHF-Kabi) was prepared from plasma from blood donors who had received an i.v. injection of DDAVP (0.2 microgram per kg b.w.) and tranexamic acid (0.01 g per kg b.w.) 15 min before collection of the blood. The factor VIII preparation from such plasma contained twice as much VIII:C,VIIIR:Ag, and VIIIR:RFC as normal fraction I-0. Normal(More)
With an interval of eight weeks between collections, blood was drawn twice from 120 blood donors. At one of the donations, 0.25 ml of synthetic vasopressin, (DDAVP, 1300 micrograms/ml), was administered intranasally 60 minutes prior to collection of the blood. No drug was given at the other donation. The yield of factor VIII clotting activity (VIII:C) and(More)
DDAVP (1-desamino-8-D-arginine vasopressin) was administered intranasally to 20 normal persons and blood was collected at various intervals up to 72 h. Plasma concentrations of VIII:C, VIIIR:Ag and fibrinolytic activity were increased by DDAVP with peak levels observed 1 h after the administration. Factors V, IX, XI, XII, XIII, P-APT time, platelets,(More)
In view of reported discrepancies between different factor VIII assays, the influence of phospholipids on the performance of one-stage clotting (OS) and chromogenic substrate (CS) assays was evaluated. The B domain deleted recombinant factor VIII, rVIII SQ, two full-length recombinant products and a plasma derived factor VIII concentrate were each diluted(More)