Corpus ID: 1130001

Pasteurization Inactivates Clotting Enzymes During Flebogamma And Flebogamma DIF Production

  title={Pasteurization Inactivates Clotting Enzymes During Flebogamma And Flebogamma DIF Production},
  author={M. Jos{\'e} and N. Marzo and M. Bono and M. Carretero and Maite López and P. Ristol and J. Jorquera},
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 steps to remove them, capacity of Pasteurisation for (pro)enzymes inactivation and presence of (pro)enzyme activities in final products from different IVIG manufacturers were… Expand
Flebogamma(®) DIF (intravenous immunoglobulin) purification process effectively eliminates procoagulant activities.
  • M. José, N. Marzo, +5 authors J. Jorquera
  • Medicine, Chemistry
  • Biologicals : journal of the International Association of Biological Standardization
  • 2013
A new manufacturing process to remove thrombogenic factors (II, VII, IX, X, and XI) from intravenous immunoglobulin gamma preparations.
Quantifying the thrombogenic potential of human plasma-derived immunoglobulin products.
Historical Aspects of Polyclonal IgG Preparations


Flebogamma® 5% DIF development: rationale for a new option in intravenous immunoglobulin therapy
  • J. Jorquera
  • Medicine, Biology
  • Clinical and experimental immunology
  • 2009
Contact-activated factors: contaminants of immunoglobulins preparations with coagulant and vasoactive properties.
Human thrombins. Production, evaluation, and properties of alpha-thrombin.
Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations
Patients with severe factor XI deficiency have a reduced incidence of deep-vein thrombosis.