A5102768265- Platelet Disorders and Treatments
- Hemophilia Treatment and Research
- Blood Coagulation and Thrombosis Mechanisms
- Blood groups and transfusion
- Complement system in diseases
- Monoclonal and Polyclonal Antibodies Research
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Hemostasis and retained surgical items
- Heparin-Induced Thrombocytopenia and Thrombosis
- Biochemical and Molecular Research
- Viral Infectious Diseases and Gene Expression in Insects
- Blood properties and coagulation
- Chronic Myeloid Leukemia Treatments
- CAR-T cell therapy research
- Cancer, Lipids, and Metabolism
- Hemoglobinopathies and Related Disorders
- Liver Disease Diagnosis and Treatment
- Metabolism and Genetic Disorders
- Antiplatelet Therapy and Cardiovascular Diseases
Takeda (Austria)
2019-2024
Baxter (Austria)
2010-2015
Baxter (United States)
2013-2015
FEIBA(®) consists of zymogens and traces activated forms procoagulant factors II, VII, IX, X, anticoagulants protein C TFPI, small amounts cofactors FV, FVIII S, in a balanced ratio. As shown previously, FII-FXa complex plays key role FEIBA's mode action (MoA).Thrombin generation (TG) was measured by spiking coagulation factors, inhibitors to high titer inhibitor plasma, plasma samples from patients phase 3 clinical study evaluating the safety efficacy FEIBA prophylaxis haemophilia A with...
Summary A longer acting recombinant FVIII is expected to serve patients’ demand for a more convenient prophylactic therapy. We have developed BAX 855, PEGylated form of Baxter’s rFVIII product ADVATE™ based on the manufacturing process. The conjugation process preparing 855 uses novel PEG reagent. production was adjusted yield conjugate with low PEGylation degree about 2 moles per molecule. This optimised modification resulted in an improved PK profile without compromising its specific...
Recombinant von Willebrand factor (rVWF, vonicog alfa) is a purified VWF concentrate produced from Chinese hamster ovary cells. rVWF not exposed to the VWF-cleaving protease ADAMTS13 and so subject proteolytic degradation of large (L) ultra-large (UL) multimers by that enzyme.To compare structure function with human plasma-derived [pdVWF] concentrates Haemate P®/Humate-P®, Voncento®, Wilate®/Eqwilate®, Wilfactin®/Willfact®; investigate relationship between multimeric pattern VWF:ristocetin...
Nonacog gamma is a new recombinant factor IX to treat deficiency. It indicated for control of bleeding episodes, perioperative management and routine prophylaxis prevent or reduce the frequency episodes in adults children with hemophilia B. was first approved USA June 2013 under trade name RIXUBIS followed by market approvals Australia EU 2014, marketing authorization decision pending Japan. derived from Chinese hamster ovary cell line using state art biotechnological manufacturing process....
Extended half-life (EHL) factor therapies are needed to reduce the burden of prophylaxis and improve treatment adherence in patients with hemophilia. BAX 826 is a novel polysialylated full-length recombinant VIII [polysialyic acid (PSA) rFVIII] improved pharmacokinetics (PK), prolonged pharmacology, maintained safety attributes enable longer-acting rFVIII therapy. In (FVIII)–deficient hemophilic mice, PSArFVIII showed substantially higher mean residence time (>2-fold) exposure...
Accurate monitoring of coagulation, needed for optimal management patients with haemophilia A inhibitors, presents a challenge treating physicians. Although global haemostatic assays may be used in this population, their utility nonfactor therapies has yet to established the clinical setting. The aim study was assess options potential activity and feasibility factor VIII (FVIII)-equivalency measurement sequence identical analogue (SIA) emicizumab using different coagulation assays. SIA...
Accurate quantification of von Willebrand factor ristocetin cofactor activity (VWF:RCo) is critical for the diagnosis and classification disease, most common hereditary acquired bleeding disorder in humans. Moreover, it important to accurately assess function (VWF) concentrates within pharmaceutical industry provide consistent high-quality biopharmaceuticals. Although performance VWF:RCo assay has been improved by using coagulation analyzers, which are specialized devices blood plasma...
BackgroundIt is essential to measure the activity of factor VIII (FVIII) throughout life cycle a coagulation FVIII concentrate. Such measurement in nonclinical pharmacokinetic studies potentially biased by presence endogenous nonhuman FVIII, and certain manufacturing process–related additives can also impact assay performance. Finally, activity–mimicking antibodies poses challenges when measuring samples. Therefore, we developed an antibody‐based chromogenic assay, which facilitates...