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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
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Philippe Appourchaux
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
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Béatrice Claudel
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
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Monique Ollivier
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
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Richard Dennett
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
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Laurent Siret
Laboratoire Français du Fractionnement et des Biotechnologies, Courtaboeuf, France †Voisin Consulting Life Sciences, Boulogne, France
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  • For correspondence: siret@lfb.fr
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References

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PDA Journal of Pharmaceutical Science and Technology: 72 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 2
March/April 2018
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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

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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
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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
  • PDF

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  • Phase-Incremental Decision Trees for Multi-Phase Feature Selection and Interaction in Biologics Manufacturing
  • Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
  • A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)
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Keywords

  • Quality by Design
  • polyvalent human normal immunoglobulins
  • intravenous immunoglobulins
  • IQYMUNE®
  • CLAIRYG®
  • quality risk management

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