title: Adventitious agents, new technology, and risk assessment, 19-20 May 2011, Baltimore, MD.
abstract: In May 2011, the International Alliance for Biological Standardization, with the cooperation of WHO, FDA, and NIAID, organized a conference on adventitious agents that might be found in biological products using new technology (http://www.iabs.org/index.php/past-conference-reports/116-baltimore-2011-slides). The implications of such findings on risk assessment also were considered. Topics that were addressed included: a) current routine testing--what are we doing now?; b) recent advances in testing--what tests are being explored/applied?; c) examples of finding agents with "new" techniques; and d) risk assessment, including recent WHO activities. A draft algorithm for risk assessment was discussed in terms of its applicability to a variety of potential new agents and the possibilities for improving it.
authors.affiliation: National Institutes of Health, National Institute of Allergy & Infectious Diseases, Bethesda, MD, USA. RSheets@niaid.nih.gov
authors.forename: Rebecca
authors.initials: R
authors.lastname: Sheets
authors.forename: Johannes
authors.initials: J
authors.lastname: Loewer
authors.forename: Gopa
authors.initials: G
authors.lastname: Raychaudhuri
authors.forename: John
authors.initials: J
authors.lastname: Petricciani
mesh_terms: D015142:Baltimore; D001688:Biological Products / Q000009:adverse effects / Q000592:standards*; D001709:Biotechnology; D004340:Drug Contamination; D006801:Humans; D008828:Microbiological Techniques; D018570:Risk Assessment
chemical_list: D001688:Biological Products