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TSE Advisory Committee Gaithersburg, Maryland - October 28-29, 2010

TSE Advisory Committee Gaithersburg, Maryland - October 28-29, 2010. Recent advances in development of devices to remove TSE agents from blood components . Luisa Gregori Div. Emerging and Transfusion-Transmitted Diseases OBRR/CBER/FDA . 1 | Gregori | TSEAC, October 28-29, 2010. BSE Deaths.

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TSE Advisory Committee Gaithersburg, Maryland - October 28-29, 2010

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  1. TSE Advisory CommitteeGaithersburg, Maryland - October 28-29, 2010 Recent advances in development of devices to remove TSE agents from blood components Luisa Gregori Div. Emerging and Transfusion-Transmitted Diseases OBRR/CBER/FDA 1|Gregori|TSEAC, October 28-29, 2010

  2. BSE Deaths 300 vCJD Deaths Is vCJD still a concern? In the U.K. 2|Gregori|TSEAC, October 28-29, 2010

  3. BSE cases by country and by year http://www.oie.int/eng/info/en_esbmonde.htm

  4. BSE Deaths vCJD Deaths Is vCJD still a concern? In the U.K. 300 4|Gregori|TSEAC, October 28-29, 2010

  5. Tissue surveys 5|Gregori|TSEAC, October 28-29, 2010

  6. Tissue surveys - Conclusions • Tissue survey studies are in agreement • Prevalence 100 to >200 infections/million of UK population • Prevalence higher than that estimated from known vCJD cases • To be considered: • Unknown time course of appearance of PrPTSE in lymphoid tissues • Undetermined specificity and sensitivity of IHC • Technical difficulties with sampling/staining of tissues • Prevalence may be underestimated 6|Gregori|TSEAC, October 28-29, 2010

  7. Conclusions • Highly likely more individuals in the UK are infected with vCJD but asymptomatic • Precautionary measures against blood-transmitted vCJD are still needed • US donor deferral policies • vCJD screening test • vCJD infectivity reduction options 7|Gregori|TSEAC, October 28-29, 2010

  8. TSEAC, Nov. 2005Validation criteria and possible label claims for devices to remove TSE infectivityfrom blood components TSEAC suggested modifications to FDA’s proposed criteria: •  3 log10 reduction of spiked infectivity (demonstrated by Western blot and bioassay) • Remove all detectable infectivity from endogenously infected animal blood •  2 animal models and 2 strains of TSE agent •  1 agent strain derived from cow with BSE or human with vCJD (rodent-adapted) • Filtered blood components should maintain functionality at expiry by usual tests Modified from David Asher

  9. TSEAC Nov. 2005 - Continuation • Desirable to demonstrate that device removes all detectable endogenous TSE infectivity from whole units of blood of large animals • Ideally bioassays should be conducted in the same species but tests in susceptible transgenic mice are also acceptable • Reproducibility of results at separate study sites is desirable • Study should be large enough for statistical validity • Studies described might support label claims for reduction of TSE infectivity from blood products Modified from David Asher

  10. Removal technologies • The process must remove infectivity associated with plasma and with white blood cells • Filter formats • Three manufacturers • Asahi-Kasei Medical – T. Yokomizo, M.Sc. • Pall Medical Corporation – S. Coker, Ph.D. • Prometic Biosciences – S. Burton, Ph.D. 10|Gregori|TSEAC, October 28-29, 2010

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