we prepared a highly purified and relatively heat stable form of factor viii which contained 25 units per ml (u/ml) activity using peg-4000 and developed an effective and new manufacturing process. heat treatment was performed at 80°c for 72 hrs in the presence of different stabilizers. in our studies, we used different organic solvents as preservatives to maintain factor viii activity, since f...

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introduction: the prevalence of rare bleeding disorders, including combined factor v+viii deficiency are higher in iran than in developed countries. there are only a few reports which have been written concerning kidney transplantation in the patients suffering from these disorders. case report: a 22-year old girl, with a known case of combined factor v+viii deficiency, a history of bladder sto...

background: factor viii inhibitor is one of the most problems in the treatment of hemophilia. patients with hemophilia who have inhibitors are capable of severe hemorrhage and treatments of these patients are more expensive and more difficult than those patients without inhibitor. the aim of present study was to determine the prevalence of inhibitor and to assess the necessity of screening of t...

Background: Considering the increasing number of patients with hemophilia and infrastructure requirements for a comprehensive approach, development of a recombinant factor has become a milestone. The objective of this study was to assess the safety, efficacy and non inferiority of Safacto (Recombinant factor VIII) compared with plasma-derived factor in the treatment of hemophilia A. Methods: 10 ...

Investigations were undertaken of the chemical nature and kinetics of interaction of three acquired inhibitors of Factor VIII. The inhibition was stoichiometric, one molecule of inhibitor (or one site on a molecule) being required to inactivate one molecule of Factor VIII. All three inhibitors were found to be monotypic antibodies of class IgG, Type K (gamma(2) kappa(2)). This appears to be the...

New and expensive therapeutic products can place great pressure on health care purchasers. Often, evidence to support the inclusion of such products in the purchasing process is lacking or confusing, yet demand can be organized and forceful. In this paper we use the example of the introduction of recombinant factor VIII (rFVIII) in the management of haemophilia A, to highlight some problems pur...

Six recombinant factor VIII (rFVIII) products have been marketed worldwide. In 2013, the Research of Determinants of Inhibitor Development (RODIN) study group reported an unexpectedly high risk of inhibitor development with a second-generation full-length rFVIII (Product D) in previously untreated patients (PUPs) with severe hemophilia A (HA). In 1994, French public health authorities establish...