The purpose of this technical report is to describe the proven, successful principles used and measures that can be taken to mitigate the risk of contamination by viruses and to provide guidance in effective preparation and response should such an event occur in manufacturing processes using in vitro mammalian or other eukaryotic cell cultures to produce biopharmaceutical products.

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Format: PDF (1 file 470 KB)

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Table of Contents:

1. Introduction
2. Glossary
3. Risk Mitigation
4. Preparation for a Virus Contamination
5. Response to a Virus Contamination
6. Conclusions
7. References

Figures and Tables Index