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. 2007 Mar;35(1):35-42.
doi: 10.1016/j.biologicals.2006.01.002. Epub 2006 Apr 3.

Pathogen inactivation and removal procedures used in the production of intravenous immunoglobulins

Christoph Kempf  1 , Martin Stucki, Nicola Boschetti
Affiliations

Pathogen inactivation and removal procedures used in the production of intravenous immunoglobulins

Christoph Kempf et al. Biologicals. 2007 Mar.

Abstract

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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Figures

Fig. 1
Fig. 1
Kistler-Nitschmann fractionation scheme for IVIG manufacturing. Filter aid is added at each depth filtration clarification step. In black cycles are the numbers of validated process steps.
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