NR AWQY
AU You,B.; Arrabal,S.; Laude,H.; Flan,B.
TI Cellular assay for in vitro TSE titration: latest improvements and possible validation as an alternative to bioassay
QU International Conference - Prion 2006: Strategies, advances and trends towards protection of society - 3.10.-6.10.2006, Torino, Italy, Lingotto Conference Centre - Poster sessions SA-16
PT Konferenz-Poster
AB Titration experiments of transmissible spongiform encephalopathies (TSE) agents, which are required for the validation of manufacturing processes of plasma derived products, involve either rapid immunochemical PrP-res detection, mostly by Western Blot (WB), or time-consuming and expensive infectivity protocols, that consist of intra-cerebral inoculation of laboratory rodents, which is the only validated method for the titration of infectivity. The LFB has developed an alternative in vitro infectivity titration assay, based on the infection of TSE permissive cells. This assay has shown several characteristics that make it an interesting alternative to the reference titration methods for measuring TSE infectivity : it is highly sensitive (~ 80 times more than WB, and comparable to bioassay), specific and reproducible. It is fast (less than 8 weeks), less expensive than bioassay and was shown to be suitable for the validation of manufacturing processes. Experiments are ongoing in order to increase the sensitivity of the assay and/or to reduce its duration. Work is also in progress regarding the validation of the assay for regulatory recognition (comparison to bioassay experiments and analytical validation). Latest developments of the tissue culture infectivity assay will be presented, and recognition by regulatory authorities will be discussed.
AD B. You, S. Arrabal, B. Flan: Laboratoire du Fractionnement et des Biotechnologies. Unité de Sécurisation Biologique. Les Ulis, France; H. Laude: Institut National de la Recherche Agronomique. Unité de Virologie Immunologie Moléculaires. Jouy-en-Josas, France
SP englisch
PO Italien