Send to

Choose Destination
See comment in PubMed Commons below
Transfusion. 2008 Jul;48(7):1342-7. doi: 10.1111/j.1537-2995.2008.01647.x. Epub 2008 Feb 22.

Clearance of dengue virus in the plasma-derived therapeutic proteins.

Author information

Advantek Serum Laboratories Limited, Shatin, N.T., Hong Kong.



Viral safety is of paramount importance for human plasma-derived therapeutic proteins. Recent reports of blood-associated transmission and continuous regional outbreaks of dengue fever have prompted a validation of clearance of dengue virus in the manufacture processes of the plasma-derived products.


A high titer of cultured dengue virus serotype 2 was spiked into process samples before individual steps of albumin and immunoglobulin manufacture processes, including cold ethanol precipitation, cation-exchange chromatography, pasteurization, solvent/detergent treatment, and virus filtration. Clearance of dengue virus was quantified with TCID(50) assays in the culture of Vero E6 cells and, when appropriate, real-time polymerase chain reaction (RT-PCR) assays.


The individual process steps were all effective in the inactivation and/or removal of dengue virus, and the data obtained clearly demonstrate that the risk of dengue virus transmission was reduced cumulatively by at least 10.12 and at least 14.24 log in the albumin and immunoglobulin manufacture processes, respectively.


The dedicated viral inactivation and/or removal approaches currently implemented in the manufacture of plasma-derived products provide a good safety margin with regard to the transmission of dengue virus.

[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Wiley
    Loading ...
    Support Center