PDA Technical Report No. 83 (TR 83) Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response (single user digital version)

Sep 2019
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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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Table of Contents

Table of Contents:

Click here to download >>> Detailed 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