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- Article
- Abstract
- Introduction
- OOS Results Obtained in an In Vitro Adventitious Agent Assay
- CPE Observed Resembled Foci Seen in Polyomavirus-Transformed Cells
- Initial Steps in Investigation into the OOS Results
- OOS Results Attributed to Biological Agent Most Likely Introduced through Contaminated Medium
- Broad, All-Inclusive Analytical Investigational Plan to Identify the Putative Contaminant
- Negative Results Obtained in Extensive Testing for Polyomavirus
- Positive Result for SV40 Attributed to Expression Vector Sequence
- Nucleic Acid–Based Screening Assays for Additional Rodent and Bovine Viruses
- Screening for Potential Contaminants of Human Origin
- Non-Specific, Broad Screening Tests
- Extended Laboratory Investigation
- Comparison of AVA Parameters in Attempt To Induce Formation of the Foci Artifact
- Further Evaluation of Biological Nature of Putative Contaminant
- On-Site Evaluation of AVA at Three Contract Labs
- Identification of Potential Root Cause for Foci Artifact
- Overall Conclusion, Outcomes, and Lessons Learned
- References
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