Adventitious agents, new technology, and risk assessment, 19-20 May 2011, Baltimore, MD

Rebecca Sheets; Johannes Loewer; Gopa Raychaudhuri; John Petricciani

doi:10.1016/j.biologicals.2012.02.001

Adventitious agents, new technology, and risk assessment, 19-20 May 2011, Baltimore, MD

Biologicals. 2012 Mar;40(2):162-7. doi: 10.1016/j.biologicals.2012.02.001. Epub 2012 Feb 24.

Authors

Rebecca Sheets¹, Johannes Loewer, Gopa Raychaudhuri, John Petricciani

Affiliation

¹ National Institutes of Health, National Institute of Allergy & Infectious Diseases, Bethesda, MD, USA. [email protected]

PMID: 22364947
DOI: 10.1016/j.biologicals.2012.02.001

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.

Publication types

Congress
Research Support, Non-U.S. Gov't

MeSH terms

Baltimore
Biological Products / adverse effects
Biological Products / standards*
Biotechnology
Drug Contamination
Humans
Microbiological Techniques
Risk Assessment

Substances

Biological Products