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Research ArticleConference Report

PDA/FDA Adventitious Agents and Novel Cell Substrates: Emerging Technologies and New Challenges, Nov. 3–4, 2011, Rockville, MD

Arifa S. Khan, Anthony Lubiniecki and Kathryn E. King
PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 502-511; DOI: https://doi.org/10.5731/pdajpst.2012.00895
Arifa S. Khan
1Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Bethesda, Maryland 20892;
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  • For correspondence: Arifa.Khan@fda.hhs.gov
Anthony Lubiniecki
2Pharmaceutical Development & Manufacturing Sciences, Janssen Research & Development, LLC, Malvern, Pennsylvania 19355; and
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Kathryn E. King
3Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Bethesda, Maryland 20892
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Abstract

In response to the challenges of addressing potential safety concerns related to the use of novel cell substrates, the Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) co-sponsored a conference on November 3–4, 2011 in Rockville, Maryland, USA. The following were discussed: the current adventitious agent testing methods and the use of emerging nucleic acid–based technologies for broad detection of known and novel viruses; issues associated with manufacture of biologicals in novel cell substrates such as insect cell lines and plants, with specific focus on potential safety concerns related to endogenous retroviral elements; and raw material controls and strategies to mitigate risk of adventitious virus contamination during product manufacture.

  • © PDA, Inc. 2012
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PDA Journal of Pharmaceutical Science and Technology: 66 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 6
November/December 2012
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PDA/FDA Adventitious Agents and Novel Cell Substrates: Emerging Technologies and New Challenges, Nov. 3–4, 2011, Rockville, MD
Arifa S. Khan, Anthony Lubiniecki, Kathryn E. King
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 502-511; DOI: 10.5731/pdajpst.2012.00895

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PDA/FDA Adventitious Agents and Novel Cell Substrates: Emerging Technologies and New Challenges, Nov. 3–4, 2011, Rockville, MD
Arifa S. Khan, Anthony Lubiniecki, Kathryn E. King
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 502-511; DOI: 10.5731/pdajpst.2012.00895
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