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Paper Information

Journal:   DARU JOURNAL OF PHARMACEUTICAL SCIENCE   2003 , Volume 11 , Number 2; Page(s) 47 To 51.
 
Paper: 

SOLVENT-DETERGENT TREATMENT OF IGM-ENRICHED IMMUNOGLOBULIN

 
 
Author(s):  POURMOKHTAR M., DINARVAND R.*, MOUSAVI HOSSEINI K., REZVAN H., JALILI M.A.
 
* DEPARTMENT OF PHARMACEUTICS, FACULTY OF PHARMACY, TEHRAN UNIVERSITY OF MEDICAL SCIENCES, TEHRAN 14174, IRAN
 
Abstract: 

Viral safety of human plasma products plays a key role in their safe uses. Solvent- detergent (SD) virus-inactivation method has gained widespread popularity in the manufacture of biological products. This treatment which inactivates lipid-enveloped viruses effectively consists of incubation of a plasma protein solution in the presence of a non-volatile organic solvent and a detergent. In this study, IgM-enriched immunoglobulin was incubated at 24 °C for 6 h under slow stirring in the presence of tri(nbutyl) phosphate (0.3% w/w ) as solvent and tween 80 (1% w/w) as detergent. After completion of the inactivation process and removal of the solvent-detergent, the ability of SD-treatment to remove Infectious Bovine Rhinotracheitis (IBR) virus (a lipid-enveloped virus) and Foot-and-Mouth Disease virus (a non-enveloped virus) were evaluated by virus spiking studies using a scaled down process. Reduction factor of 4 log was obtained for the SD-treatment of IgM-enriched immunoglobulin spiked with IBR virus. No virus inactivation was observed in the SD-treated IgM-enriched immunoglobulin, spiked with Foot-and-Mouth Disease virus. It was concluded that treatment of IgM-enriched immunoglobulin with TNBP-TWEEN 80 may be considered as an efficient lipid-enveloped virus inactivation step in the manufacture of this product.

 
Keyword(s): SOLVENT-DETERGENT, VIRUS INACTIVATION, IGM, TWEEN 80, BOVINE RHINOTRACHEITIS VIRUS
 
References: 
 
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