Evaluation of the impact of the upstream bioprocess parameters on the proteomic profile of recombinant factor IX

2021 ◽  
Author(s):  
◽  
Dinora Roche Recinos
Keyword(s):  
Factor Ix ◽  
Proteomic Profile ◽  
Recombinant Factor Ix ◽  
The Impact

Recombinant Factor IX

1997 ◽  
Vol 78 (01) ◽  
pp. 261-265 ◽  
Author(s):  
Gilbert C White ◽  
Aime Beebe ◽  
Brenda Nielsen
Keyword(s):  
Factor Ix ◽  
Recombinant Factor Ix

Nonacog Alpha - an Efficient Therapeutic Option in Hemostase Management for Hemophilia Type B in Patients with Elective Arthropalsties

2018 ◽  
Vol 69 (7) ◽  
pp. 1911-1914
Author(s):  
Oana Viola Badulescu ◽  
Razvan Tudor ◽  
Wilhelm Friedl ◽  
Manuela Ciocoiu ◽  
Paul Dan Sirbu
Keyword(s):  
Therapeutic Option ◽  
Coagulation Factors ◽  
Factor Ix ◽  
Joint Disease ◽  
Type B ◽  
Total Endoprosthesis ◽  
Recombinant Factor Ix ◽  
Bleeding Episodes ◽  
Low Incidence ◽  
Articular Pathology

Hemophilia is a hereditary coagulopathy that is largely in the attention of developing countries, not because of its low incidence, but because of the high costs involved in the treatment of the disease and its disabling consequences of the disease, if treated inappropriately. The concentrates of coagulation factors currently available for the substitution treatment of hemophilic patients have undergone additional viral purification and inactivation techniques, in order to achieve a higher infectious safety, an aspect that also implies an increase in treatment costs for these patients. Currently, the major morbidity of patients with hemophilia is represented by the disabling articular pathology, secondary to repetitive bleeding episodes developed in the articular space. Although it has been proved that the prophylactic administration of coagulation factors helps to prevent joint disease in the case of patients that were not subject to prophylaxis, the repeated bleeding in the joints induces synovitis, which is irreversible and may progress despite subsequent prophylaxis. Under these conditions, total joint arthroplasty remains the only solution to reduce both, pain and subsequent bleeding episodes of hemophilic arthropathy. Effective hemostasis is a basic condition for successful interventions in hemophilic patients. In this regard, this paper aims to highlight the effectiveness of Nonacog Alpha, a product that contains recombinant factor IX, in the management of hemostasis, in the case of a patient with type B hemophilia, with indication of total endoprosthesis of the left hip.

Pharmacokinetics of plasma-derived and recombinant factor IX - implications for prophylaxis and on-demand therapy

Haemophilia ◽  
2013 ◽  
Vol 19 (6) ◽  
pp. 808-813 ◽  
Author(s):  
S. Björkman
Keyword(s):  
Factor Ix ◽  
On Demand ◽  
Recombinant Factor Ix

scholarly journals Treatment of hemophilia B: focus on recombinant factor IX

2013 ◽  
pp. 33 ◽  
Author(s):  
Massimo Franchini ◽  
Frattini ◽  
Crestani ◽  
Sissa ◽  
Bonfanti
Keyword(s):  
Factor Ix ◽  
Hemophilia B ◽  
Recombinant Factor Ix

scholarly journals Long-term safety and efficacy of extended-interval prophylaxis with recombinant factor IX Fc fusion protein (rFIXFc) in subjects with haemophilia B

2017 ◽  
Vol 117 (03) ◽  
pp. 508-518 ◽  
Author(s):  
K.John Pasi ◽  
Kathelijn Fischer ◽  
Margaret Ragni ◽  
Beatrice Nolan ◽  
David J. Perry ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Ix ◽  
Safety And Efficacy ◽  
Haemophilia B ◽  
Treatment Groups ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix ◽  
Bleeding Episodes ◽  
Supplementary Material

SummaryThe safety, efficacy, and prolonged half-life of recombinant factor IX Fc fusion protein (rFIXFc) were demonstrated in the Phase 3 B-LONG (adults/adolescents ≥12 years) and Kids B-LONG (children <12 years) studies of subjects with haemophilia B (≤2 IU/dl). Here, we report interim, long-term safety and efficacy data from B-YOND, the rFIXFc extension study. Eligible subjects who completed B-LONG or Kids B-LONG could enrol in B-YOND. There were four treatment groups: weekly prophylaxis (20–100 IU/kg every 7 days), individualised prophylaxis (100 IU/kg every 8–16 days), modified prophylaxis (further dosing personalisation to optimise prophylaxis), and episodic (ondemand) treatment. Subjects could change treatment groups at any point. Primary endpoint was inhibitor development. One hundred sixteen subjects enrolled in B-YOND. From the start of the parent studies to the B-YOND interim data cut, median duration of rFIXFc treatment was 39.5 months and 21.9 months among adults/adolescents and children, respectively; 68/93 (73.1 %) adults/adolescents and 9/23 (39.1 %) children had ≥100 cumulative rFIXFc exposure days. No inhibitors were observed. Median annualised bleeding rates (ABRs) were low in all prophylaxis regimens: weekly (≥12 years: 2.3; <6 years: 0.0; 6 to <12 years: 2.7), individualised (≥12 years: 2.3; 6 to <12 years: 2.4), and modified (≥12 years: 2.4). One or two infusions were sufficient to control 97 % (adults/adolescents) and 95 % (children) of bleeding episodes. Interim data from B-YOND are consistent with data from B-LONG and Kids B-LONG, and confirm the longterm safety of rFIXFc, absence of inhibitors, and maintenance of low ABRs with prophylactic dosing every 1 to 2 weeks.Supplementary Material to this article is available online at www.thrombosis-online.com.

Thrombin-activatable fibrinolysis inhibitor and the risk for recurrent venous thromboembolism

Blood ◽  
2004 ◽  
Vol 103 (10) ◽  
pp. 3773-3776 ◽  
Author(s):  
Sabine Eichinger ◽  
Verena Schönauer ◽  
Ansgar Weltermann ◽  
Erich Minar ◽  
Christine Bialonczyk ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Factor Ix ◽  
Coagulation System ◽  
Thrombin Activatable Fibrinolysis Inhibitor ◽  
Recurrent Venous Thromboembolism ◽  
Fibrinolysis Inhibitor ◽  
Viii And Ix ◽  
Low Levels ◽  
The Impact ◽  
Risk Factor For Recurrence

Abstract The impact of fibrinolysis for predicting the risk for recurrent venous thromboembolism (VTE) is low. We prospectively followed up 600 patients with a first VTE and evaluated the thrombin-activatable fibrinolysis inhibitor (TAFI) as a risk factor for recurrence. A high TAFI level (75th or higher percentile in thrombosis patients) was associated with a 2-fold higher risk for recurrence compared with lower levels. The probability of recurrence 2 years after anticoagulation was 14.5% (95% confidence interval [CI], 8.6-20.4) among patients with high TAFI levels and 6.8% (95% CI, 4.3-9.3) among patients with lower levels (P = .006). Our data also support the concept of a linkage between fibrinolysis and the coagulation system. Patients with high TAFI levels had significantly higher levels of factors XI, VIII, and IX, and a high risk of recurrence was seen among patients with high TAFI levels and high levels of one of these factors. The relative risk (RR) for recurrence was highest among patients with high TAFI and high factor XI (RR, 2.9; 95% CI, 1.3-6.9), high factor VIII (RR, 6.5; 95% CI, 2.9-14.8), or high factor IX (RR, 2.0; 95% CI, 1.0-3.9) levels compared with patients with low levels of TAFI and one of these factors.

scholarly journals Switching to recombinant factor IX Fc fusion protein prophylaxis results in fewer infusions, decreased factor IX consumption and lower bleeding rates

2014 ◽  
Vol 168 (1) ◽  
pp. 113-123 ◽  
Author(s):  
Jerry Powell ◽  
Amy Shapiro ◽  
Margaret Ragni ◽  
Claude Negrier ◽  
Jerzy Windyga ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Ix ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix

Recombinant factor IX: discrepancies between one-stage clotting and chromogenic assays

Haemophilia ◽  
2014 ◽  
Vol 20 (6) ◽  
pp. 891-897 ◽  
Author(s):  
H. V. Wilmot ◽  
J. Hogwood ◽  
E. Gray
Keyword(s):  
Factor Ix ◽  
One Stage ◽  
Recombinant Factor Ix

scholarly journals Real‐world data demonstrate improved bleed control and extended dosing intervals for patients with haemophilia B after switching to recombinant factor IX Fc fusion protein (rFIXFc) for up to 5 years

Haemophilia ◽  
2020 ◽  
Vol 26 (6) ◽  
pp. 975-983
Author(s):  
Amy Shapiro ◽  
Ateefa Chaudhury ◽  
Michael Wang ◽  
Miguel Escobar ◽  
Elisa Tsao ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Real World ◽  
Factor Ix ◽  
Real World Data ◽  
World Data ◽  
Haemophilia B ◽  
Fc Fusion Protein ◽  
Recombinant Factor Ix ◽  
Dosing Intervals
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