Abstract
In the past three decades, the use of tumorigenic cell substrates has been the topic of five Vaccine and Related Biological Products Advisory Committee (VRBPAC) meetings, including a review of the A549 cell line in September 2012. Over that period of time, major technological advances in biotechnology have improved our ability to assess the risk associated with using a tumorigenic cell line. As part of the September 2012 review, we assessed the history of A549 cells and evaluated the probable transforming event based on patterns of mutations to cancer genes. In addition, massively parallel sequencing was used to first screen then augment the characterization of A549 cells by searching for the presence of hidden viral threats using sequencing of the entire cellular transcriptome and comparing sequences to a curated viral sequence database. Based upon the combined results of next-generation sequencing technology along with standard cell characterization as outlined in published regulatory guidances, we believe that A549 cells pose no more risk than any other cell substrate for the manufacture of vaccines.
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
- MPS Method
- Identification of Viral Sequences and Interpretation of Results
- The A549 Transformation Event
- Induction of Somatic Cancer Gene Defects By Environmental Factors Versus Perturbation By Viruses
- A549 Release Testing and Characterization
- MPS Assessment of Viruses Within A549 Cells
- September 2012 VRBPAC
- Discussion
- Acknowledgements
- Footnotes
- References
- Figures & Data
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