title: Transmissible Spongiform Encephalopathies. Managing risk in mammalian organs, cells and sera. 15-16 March 1999, San Diego, CA, USA.
abstract: The aim of this conference was to review the risks posed by potential contamination of biopharmaceutical products with the causal agents of Transmissible Spongiform Encephalopathies (TSEs). These agents have become of particular concern with the BSE epidemic in the UK and with a proposed link between BSE and a new variant form of Creutzfeldt-Jakob disease (nvCJD) which occurs at significantly higher incidence in the UK. The conference particularly focused on the potential for contamination of products derived from human blood, where donors are clinically diagnosed as being infected with either classical CJD or nvCJD. Manufacturing steps, with the potential for the removal of TSE agents, were also discussed, along with the strategies available for demonstrating the effectiveness of such steps. Early diagnosis of TSE infection still represents the most effective strategy for the prevention of TSE contamination of biopharmaceutical products, and progress towards the development of assays with sufficient sensitivity to detect TSE contamination either in the raw start material or in donors was discussed.
authors.affiliation: Q-One Biotech Ltd, Todd Campus, West of Scotland, Science Park, Glasgow, G20 0XA, Scotland. Andy_Bailey@email.msn.com
authors.forename: A C
authors.initials: AC
authors.lastname: Bailey