Abstract
From an industrial perspective, the conventional in vitro and in vivo assays used for detection of viral contaminants have shown their limitations, as illustrated by the unfortunate detection of porcine circovirus contamination in a licensed rotavirus vaccine. This contamination event illustrates the gaps within the existing adventitious agent strategy and the potential use of new broader molecular detection methods. This paper serves to summarize current testing approaches and challenges, along with opportunities for the use of these new technologies.
LAY ABSTRACT: Testing of biological products is required to ensure the safety of patients. Recently, a licensed vaccine was found to be contaminated with a virus. This contamination did not cause a safety concern to the patients; however, it highlights the need for using new testing methods to control our biological products. This paper introduces the benefits of these new tests and outlines the challenges with the current tests.
- Adventitious agents
- Virus detection assays
- Viral vaccines
- Cell substrates
- Biological products
- Product safety
- Next-Generation Sequencing
- Regulatory harmonization
Footnotes
CONFERENCE PROCEEDING: Proceedings of the PDA/FDA Advanced Technologies for Virus Detection in the Evaluation of Biologicals Conference: Applications and Challenges Workshop in Bethesda, MD, USA; November 13-14, 2013
Guest Editors: Arifa S. Khan (Rockville, MD), Dominick Vacante (Malvern, PA)
- © PDA, Inc. 2014
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- Article
- Abstract
- Introduction
- Routine Testing Strategy for Viral Adventitious Agents
- Adventitious Agent Testing Key Challenges
- Potential Applications and Perspectives for New Molecular Methods
- Challenges and Opportunities for the Introduction of Alternative Broad Molecular Detection Methods
- Conclusion and Perspectives
- Conflict of Interest Declaration
- Acknowledgments
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