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- Published online March 23, 2018.
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- previous version (November 20, 2017 - 18:35).
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© PDA, Inc. 2018
Author Information
- Philippe Paolantonacci,
- Philippe Appourchaux,
- Béatrice Claudel,
- Monique Ollivier,
- Richard Dennett and
- Laurent Siret*
- Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
- ↵* Corresponding Author: Laboratoire Français du Fractionnement et des Biotechnologies, 3 avenue des Tropiques, BP 40305, 91958 Courtaboeuf cedex, France; e-mail: siret{at}lfb.fr
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- Article
- Abstract
- Introduction
- Stage 1: Product/Process Design—Quality Target Product Profile (QTPP)
- Stage 2: Product Risk Analysis—Identification of Critical Quality Attributes (CQAs)
- Stage 3: Process Risk Analysis—Identification of Critical Steps
- Stage 4: Process Risk Mitigation, Robustness Studies—Critical Process Parameters (CPPs) With Proven Acceptable Ranges (PARs)
- Stage 5: Control Strategy (CS)
- Conclusion
- Conflict of Interest Declaration
- Acknowledgments
- References
- Figures & Data
- References
- Info & Metrics
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