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Preparation and Pathogen Inactivation of Double Dose Buffy Coat Platelet Products using the INTERCEPT Blood System
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Pathogen inactivation and removal procedures used in the production of intravenous immunoglobulins

Christoph Kempf1, Martin Stucki, Nicola Boschetti

  • 1ZLB Behring AG, Wankdorfstr. 10, CH-3000 Bern 22, Switzerland.

Biologicals : Journal of the International Association of Biological Standardization
|April 4, 2006
PubMed

Patients with immunodeficiencies or some types of autoimmune diseases rely on a safe therapy with intravenous immunoglobulins (IVIGs) manufactured from human plasma, the only available source for this therapeutic. Since plasma is predisposed to contamination by a variety of blood-borne pathogens, ascertaining and ensuring the pathogen safety of plasma-derived therapeutics is a priority among manufacturers. State-of-the-art manufacturing processes provide a high safety standard by incorporating virus elimination procedures into the manufacturing process. Based on their mechanism these procedures are grouped into three classes: partitioning, inactivation, and virusfiltration.

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