Research ArticleConference Proceeding
Apparent Virus Contamination in Biopharmaceutical Product at Centocor
Linda C. Hendricks, Jarrat Jordan, Tong-Yuan Yang, Paul Driesprong, Gert Jan Haan, Mareike Viebahn, Thomas Mikosch, Henri Van Drunen and Anthony S. Lubiniecki
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 471-480;
Linda C. Hendricks
Jarrat Jordan
Tong-Yuan Yang
Paul Driesprong
Gert Jan Haan
Mareike Viebahn
Thomas Mikosch
Henri Van Drunen

References
- 1.↵
- Huschtscha L. I,
- Holliday R.
- 2.↵
- Potts BJ,
- Sawyer M,
- Shekarchi IC,
- Wismer T,
- Huddleston D
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 5
September/October 2010
Apparent Virus Contamination in Biopharmaceutical Product at Centocor
Linda C. Hendricks, Jarrat Jordan, Tong-Yuan Yang, Paul Driesprong, Gert Jan Haan, Mareike Viebahn, Thomas Mikosch, Henri Van Drunen, Anthony S. Lubiniecki
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 471-480;
Apparent Virus Contamination in Biopharmaceutical Product at Centocor
Linda C. Hendricks, Jarrat Jordan, Tong-Yuan Yang, Paul Driesprong, Gert Jan Haan, Mareike Viebahn, Thomas Mikosch, Henri Van Drunen, Anthony S. Lubiniecki
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 471-480;
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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
- Figures & Data
- Info & Metrics
- References
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