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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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Abstract

Polyvalent human normal immunoglobulins for intravenous use (IVIg), indicated for rare and often severe diseases, are complex plasma-derived protein preparations. A quality by design approach has been used to develop the Laboratoire Français du Fractionnement et des Biotechnologies new-generation IVIg, targeting a high level of purity to generate an enhanced safety profile while maintaining a high level of efficacy. A modular approach of quality by design was implemented consisting of five consecutive steps to cover all the stages from the product design to the final product control strategy.

A well-defined target product profile was translated into 27 product quality attributes that formed the basis of the process design. In parallel, a product risk analysis was conducted and identified 19 critical quality attributes among the product quality attributes. Process risk analysis was carried out to establish the links between process parameters and critical quality attributes. Twelve critical steps were identified, and for each of these steps a risk mitigation plan was established.

Among the different process risk mitigation exercises, five process robustness studies were conducted at qualified small scale with a design of experiment approach. For each process step, critical process parameters were identified and, for each critical process parameter, proven acceptable ranges were established. The quality risk management and risk mitigation outputs, including verification of proven acceptable ranges, were used to design the process verification exercise at industrial scale.

Finally, the control strategy was established using a mix, or hybrid, of the traditional approach plus elements of the quality by design enhanced approach, as illustrated, to more robustly assign material and process controls and in order to securely meet product specifications.

The advantages of this quality by design approach were improved process knowledge for industrial design and process validation and a clear justification of the process and product specifications as a basis for control strategy and future comparability exercises.

  • Quality by design
  • Polyvalent human normal immunoglobulins
  • Intravenous immunoglobulins
  • IQYMUNE®
  • CLAIRYG®
  • Quality risk management
  • © PDA, Inc. 2018
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In This Issue

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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  • 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
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    • Acknowledgments
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  • 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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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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