<i>In vitro</i> study of a triple‐secured von Willebrand factor concentrate

Mazurier, Claudine; Poulle, Michel; Samor, Bruno; Hilbert, Lysiane; Chtourou, Sami

doi:10.1111/j.0042-9007.2004.00398.x

Cited by 21 publications

(23 citation statements)

References 18 publications

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“…Haemate P/Humate-P contains approximately two to three times more VWF:RCo than FVIII:C. Alphanate contains similar relative amounts of FVIII:C and VWF:RCo. Additional in-vitro studies have included measurement of VWF:CB and analysis of VWF multimeric structure, results of which confirm substantial variations between the concentrates [8,30].…”

Section: Studies Comparing Concentrate Contentsmentioning

confidence: 90%

“…1) [8,9,17,21,[25][26][27][28][29][30][31][32]; differences in content have been noted between batches of the same product as well [8,[24][25][26][27]33]. In a study of six VWF-containing FVIII concentrates, specific activity (i.e., ratio of VWF:RCo to total protein content) varied considerably (from 5 to >100 IU VWF:RCo/mg total protein) [8].…”

Section: Studies Comparing Concentrate Contentsmentioning

confidence: 99%

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Von Willebrand factor/factor VIII concentrates in the treatment of von Willebrand disease

Batlle

López-Fernández

Fraga

et al. 2009

Blood Coagulation &Amp; Fibrinolysis

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Therapy for von Willebrand disease (VWD) aims to restore the hemostatic function conferred by von Willebrand factor (VWF), which facilitates platelet adhesion and aggregation, and serves to increase potentially low coagulation factor VIII (FVIII) in plasma. In patients unresponsive to desmopressin (DDAVP), the preferred treatment is with plasma-derived VWF-containing FVIII concentrates. Only a few of the available VWF/FVIII concentrates have been licensed for use in VWD based on prospective studies. The efficacy of VWF/FVIII concentrates depends on the content and quality of VWF and FVIII. Several studies have demonstrated the variability of the VWF contents, as well as the differences in the VWF multimer patterns (including the high molecular weight VWF multimers that are most effective in restoring hemostasis), among these concentrates. Treating physicians should be aware of these disparities and the potential clinical implications for patients with different VWD subtypes. Dosing has traditionally been calculated based on the FVIII content of the products, although dosing based on VWF functional activity [e.g., VWF ristocetin cofactor activity (VWF:RCo)] addresses the primary protein deficiency in VWD patients. Several clinical studies have demonstrated the efficacy of concentrates dosed according to VWF:RCo. Dosing is generally consistent across VWD subtypes, although patients with severe phenotypes or undergoing major procedures may require more infusions or longer treatment duration. Other considerations for the use of VWF-containing concentrates include laboratory monitoring of efficacy and safety issues such as thrombosis risk and thromboprophylaxis.

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Section: Studies Comparing Concentrate Contentsmentioning

confidence: 90%

Section: Studies Comparing Concentrate Contentsmentioning

confidence: 99%

Von Willebrand factor/factor VIII concentrates in the treatment of von Willebrand disease

Batlle

López-Fernández

Fraga

et al. 2009

Blood Coagulation &Amp; Fibrinolysis

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“…Viral inactivation/elimination included three steps: solvent‐detergent treatment, 35 nm nanofiltration and dry heating of the lyophilized product at 80 °C for 72 h. The manufacturing process as well as the viral reduction efficacy of each step were evaluated using model or pertinent viruses as described earlier. [8] Comparison of agarose gel electrophoresis of the concentrate and normal plasma showed only a limited defect of high‐molecular weight VWF multimers and no signs of enhanced proteolysis (Fig. 1).…”

Section: Methodsmentioning

confidence: 99%

“…[5–7] An improved version of this concentrate (Wilfactin ® ; LFB) was recently developed in order to further reduce the risk of transmission of non‐enveloped viruses and prions. [8] The pharmacokinetic profiles of Wilfactin ® and Facteur Willebrand‐LFB ® were illustrated to be comparable in a cross‐over randomized trial, indicating that the VWF molecules are not altered by the three virus inactivation/removal steps included in the Wilfactin ® manufacturing process. [9] This report groups the results of two distinct but comparable prospective, non‐controlled, open‐label, multicenter studies ( European and French studies) designed to evaluate the efficacy and safety of Wilfactin ® for the prevention or treatment of bleeding in 50 patients with clinically severe forms of VWD unresponsive to desmopressin.…”

Section: Introductionmentioning

confidence: 99%

Treatment of severe von Willebrand disease with a high‐purity von Willebrand factor concentrate (Wilfactin®): a prospective study of 50 patients

Borel‐Derlon

Federici

Roussel-Robert

et al. 2007

Journal of Thrombosis and Haemostasis

110

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) were treated with the concentrate as the only therapy, except for clinical situations requiring a priming dose of FVIII to rapidly correct an intrinsic coagulation defect. A total of 139 spontaneous bleeding episodes were treated; only 53 (38%) needed a concomitant FVIII dose. Outcome was excellent or good in 89% of the episodes. Forty-four patients underwent 108 surgical or invasive procedures. Outcome was excellent or good in 95 scheduled procedures (only VWF was infused) and 13 emergency procedures (a priming FVIII dose was co-administered with the first VWF infusion). There were no thrombotic complications and none of the 18 patients with type 3 VWD developed anti-VWF or anti-FVIII antibodies. Conclusions. This concentrate safely and effectively provides hemostasis in patients with clinically severe VWD.

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“…41 Viral reduction is by SD, 35-nm nanofiltration, and terminal dry heat at 808C for 72 hours. 42 Fibrinogen. There are 5 registered fibrinogen preparations available for treating a fibrinogenemia or hypofibrinogenemia.…”

Section: Coagulation Factorsmentioning

confidence: 99%

Modern Plasma Fractionation

Burnouf¹

2007

Transfusion Medicine Reviews

219

196

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Protein products fractionated from human plasma are an essential class of therapeutics used, often as the only available option, in the prevention, management, and treatment of life-threatening conditions resulting from trauma, congenital deficiencies, immunologic disorders, or infections. Modern plasma product production technology remains largely based on the ethanol fractionation process, but much has evolved in the last few years to improve product purity, to enhance the recovery of immunoglobulin G, and to isolate new plasma proteins, such as alpha1-protease inhibitor, von Willebrand factor, and protein C. Because of the human origin of the starting material and the pooling of 10,000 to 50,000 donations required for industrial processing, the major risk associated to plasma products is the transmission of blood-borne infectious agents. A complete set of measures--and, most particularly, the use of dedicated viral inactivation and removal treatments--has been implemented throughout the production chain of fractionated plasma products over the last 20 years to ensure optimal safety, in particular, and not exclusively, against HIV, hepatitis B virus, and hepatitis C virus. In this review, we summarize the practices of the modern plasma fractionation industry from the collection of the raw plasma material to the industrial manufacture of fractionated products. We describe the quality requirements of plasma for fractionation and the various treatments applied for the inactivation and removal of blood-borne infectious agents and provide examples of methods used for the purification of the various classes of plasma protein therapies. We also highlight aspects of the good manufacturing practices and the regulatory environment that govern the whole chain of production. In a regulated and professional environment, fractionated plasma products manufactured by modern processes are certainly among the lowest-risk therapeutic biological products in use today.

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In vitro study of a triple‐secured von Willebrand factor concentrate

Abstract: We have perfected a large-scale manufacturing process to produce a human plasma-derived VWF concentrate that boasts high specific activity and is very safe for the treatment of patients with von Willebrand disease.

Cited by 21 publications

References 18 publications

Von Willebrand factor/factor VIII concentrates in the treatment of von Willebrand disease

Von Willebrand factor/factor VIII concentrates in the treatment of von Willebrand disease

Treatment of severe von Willebrand disease with a high‐purity von Willebrand factor concentrate (Wilfactin®): a prospective study of 50 patients

Modern Plasma Fractionation

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