Case ReportCase Studies
Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design—A Worked-through Case Study
Philippe Paolantonacci, Philippe Appourchaux, Béatrice Claudel, Monique Ollivier, Richard Dennett and Laurent Siret
PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 176-187; DOI: https://doi.org/10.5731/pdajpst.2016.007393
Philippe Paolantonacci
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
Philippe Appourchaux
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
Béatrice Claudel
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
Monique Ollivier
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
Richard Dennett
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
Laurent Siret
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 2
March/April 2018
Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design—A Worked-through Case Study
Philippe Paolantonacci, Philippe Appourchaux, Béatrice Claudel, Monique Ollivier, Richard Dennett, Laurent Siret
PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 176-187; DOI: 10.5731/pdajpst.2016.007393
Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design—A Worked-through Case Study
Philippe Paolantonacci, Philippe Appourchaux, Béatrice Claudel, Monique Ollivier, Richard Dennett, Laurent Siret
PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 176-187; DOI: 10.5731/pdajpst.2016.007393
Jump to section
- 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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