NR AOZX
AU Truchot,L.; Bloy,C.; Streichenberger,N.; Perret-Liaudet,A.
TI CJD PrPsc in biopharmaceutical product removal by nanofiltration process
QU International Conference - Prion diseases: from basic research to intervention concepts - TSE-Forum, 08.10.-10.10.2003, Gasteig, München - Poster session - BR-35
PT Konferenz-Poster
AB
The characteristic of transmissible spongiform encephalopathies (TSE) is an accumulation of abnormal isoform of prion protein (PrPsc) partially proteinase resistant (PrPres). The risk of TSE as Creutzfeldt-Jakob disease (CJD) transmission by biopharmaceutical products prepared from human cells must be taken into account. Nanofiltration process has been proved to be effective to remove viruses and scrapie (1). The major advantages of this technique consist in its flexibility and its efficiency for removal infectious particles with an absence of denaturing biopharmaceutical effects.
This study was focused on the removal PrPsc after spiking CJD brain homogenate to biopharmaceutical products.
Lymphoglobuline(r) is an anti-thymocyte equine immunoglobulin prepared from thymocytes, placental and red human cells. It induces T-cell depletion and immune modulation. In our study, CJD homogenate was spiked at three different dilutions(weak, moderate, high) in a solution of Lymphoglobuline(r). Nanofiltration steps were realised on each sample. PrPres detection by western blot technique was compared to a reference scale (2) (dilution series of CJD brain homogenate in Lymphoglobuline(r) detected by western blot and elaborated on 3.3 logs). After nanofiltration, PrPres western-blot signal was detected with significant reduction in the lowest diluted sample, whereas the signal was negative in the two other samples (in the limit of the western blot detection).
Our data demonstrated > 2.3 log clearance with a recovery of over Lymphoglobuline(r) of 93%. Results of this study are in agreement with nanofiltration data in the literature.
(1) : Tateishi J et al (2001) Scrapie removal using Planova(r) virus removal filters. Biologicals, 29, 17-25.
(2) : Lee D.C et al (2000) Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. Journal of Virological Methods, 84, 77-89.
AD L. Truchot, N. Streichenberger, A. Perret-Liaudet, Hôpital Neurologique Lyon, France; C. Bloy, Imtix-Sangstat Society Lyon, France
SP englisch
PO Deutschland