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Biologicals ; 40(2): 162-7, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22364947

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.


Subject(s)
Biological Products/standards , Baltimore , Biological Products/adverse effects , Biotechnology , Drug Contamination , Humans , Microbiological Techniques , Risk Assessment
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