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Abstract: In 2010, an unexpected increase in the reporting rate of serious thromboembolic adverse events associated with the application of immunoglobulin preparations from one specific manufacturer caused increased concern regarding this topic. As a result, monographs for immunoglobulin preparations were revised. Hence, plasma ..

Abstract: The recent revision of the European Pharmacopoeia stipulates that all intravenous immunoglobulin solutions must be investigated with respect to procoagulant activity. Accordingly, the manufacturing processes must be validated regarding the removal of such compounds, to ensure a minimized thromboembolic risk for patient..

Abstract : One of the most common causes of death is cancer. The traditional cancer treatments are rarely curative for disseminated cancers. Lately another approach in cancer therapy has been proposed – immunotherapy with cancer vaccines. In this review article we discuss different types of cancer vaccine, which include viral, ..

Abstract: During the year 2010 a surprising increase of thromboembolic events (TEEs) was observed after administration of distinct Octagam® 5% (human normal immunoglobulin 50 mg/ml) batches to patients. Immediately, Octapharma initiated a massive voluntary recall of Octagam batches from EU and US markets in August 2010. In Euro..

Abstract: Background: Residual content of activated procoagulant components, particularly FXIa, has been suggested to play a relevant role in the increased thrombogenic potential of intravenous immunoglobulin (IVIG) from a specific manufacturer.Methods: Flebogamma, Flebogamma DIF and other marketed IVIG preparations (products A ..

Abstract: Intravenous immunoglobulins cause thromboembolic events at a frequency of 2-3%. Complications of this nature can be life threatening. Nevertheless, a test for thrombogenicity such as non activated partial thromboplastin time is not mandatory for these drugs. As a result of recent incidents we have performed experiments..

Abstract: 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 in the starting fraction (Fr) II+III employed for Flebogamma & Flebogamma DIF(Grifols) production, capacity of purification..

Abstract: 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 in the starting fraction (Fr) II+III employed for Flebogamma and Flebogamma DIF (Grifols) production, capacity of purifica..

Abstract: Background: Residual content of activated procoagulant components, particularly FXIa, has been suggested to play a relevant role in the increased thrombogenic potential of intravenous immunoglobulin (IVIG) from a specific manufacturer.Methods: Flebogamma, Flebogamma DIF and other marketed IVIG preparations (products A ..

Abstract: During the year 2010 a surprising increase of thromboembolic events (TEEs) was observed after administration of distinct Octagam® 5% (human normal immunoglobulin 50 mg/ml) batches to patients. Immediately, Octapharma initiated a massive voluntary recall of Octagam batches from EU and US markets in August 2010. In Euro..