Pathogen inactivation and removal procedures used in the production of intravenous immunoglobulins.
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.
Kempf
Christoph
C
ZLB Behring AG, Wankdorfstr. 10, CH-3000 Bern 22, Switzerland.
Stucki
Martin
M
Boschetti
Nicola
N
D001327:Autoimmune Diseases / Q000628:therapy*; D004340:Drug Contamination; D006358:Hot Temperature; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000302:isolation & purification* / Q000592:standards*; D010949:Plasma / Q000737:chemistry; D017096:Prion Diseases / Q000517:prevention & control; D011328:Prions / Q000302:isolation & purification; D016511:Severe Combined Immunodeficiency / Q000628:therapy; D019562:Viral Load; D038301:Virus Inactivation; D014780:Viruses / Q000302:isolation & purification*
D016756:Immunoglobulins, Intravenous; D011328:Prions