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[Development and characterization of a high-purity human factor VIII concentrate submitted to 2 specific virus inactivation treatments (FANDHI)].
AIM To develop a therapeutic human high purity FVIII concentrate, treated with two documented and complementary specific inactivation methods, for the treatment of haemophilia A. MATERIAL ANDExpand
Pasteurization Inactivates Clotting Enzymes During Flebogamma And Flebogamma DIF Production
Background:A recent thromboembolic adverse events outbreak linked to a specific intravenous immunoglobulin (IVIG) brand has raised serious safety concerns. Methods: Clotting (pro)enzyme activities inExpand
Characterization and viral safety validation study of a pasteurized therapeutic concentrate of antithrombin III obtained through affinity chromatography.
BACKGROUND AND OBJECTIVE Antithrombin III (ATIII) concentrates are employed as therapy for congenital or acquired deficiencies. These concentrates are obtained from Cohn's fraction IV1. To improveExpand
[Evaluation of viral safety of a high-purity human factor VIII concentrate submitted to 2 specific virus inactivation treatments (FANDHI)].
AIM To perform a validation study of the production process of a human high purity FVIII concentrate, obtained by affinity chromatography and treated with solvent-detergent and 80 degrees C, 72- hourExpand
Hyperimmune immunoglobulins: Manufacturing technologies and safety procedures
Abstract Instituto Grifols has developed two different sterile and ready to use anti-hepatitis B (anti-HB) enriched immunoglobulin concentrates: Niuliva® is a 5% intravenous immunoglobulin solutionExpand
Physico-chemical and analytical studies on plafibride.
Physico-chemical and analytical studies on N-2-(p-chlorophenoxy)-isobutyryl)-N'-morpholinomethylurea (plafibride, ITA 104) are reported. Besides the usual analytical data, spectral (UV, IR, NMR, MS)Expand