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Review ArticleReview

Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry

Mario Stassen, Catarina S. Leitão, Toni Manzano, Francisco Valero, Benjamin Stevens, Matt Schmucki, David Hubmayr, Ferran Mirabent Rubinat, Sandrine Dessoy and Antonio Moreira
PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 68-87; DOI: https://doi.org/10.5731/pdajpst.2024.012950
Mario Stassen
1Department of Life Sciences Innovation, Stassen Pharmaconsult BV, Aerdenhout, The Netherlands;
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  • For correspondence: mmhstassen@gmail.com
Catarina S. Leitão
2Data Science Department, ValGenesis Portugal, R. Castilho 50 4th Floor, 1250-071 Lisboa, Portugal;
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Toni Manzano
3Aizon, Carrer de Còrsega 301, 08008 Barcelona, Spain;
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Francisco Valero
4Department of Chemical, Biological and Environmental Engineering, School of Engineering, Universitat Autònoma de Barcelona, 08193 Barcelona, Spain;
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Benjamin Stevens
5GSK, 1250 S. Collegeville Road, Collegeville, PA 19426, USA;
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Matt Schmucki
6Vertex Pharmaceuticals, Cincinnati, OH, USA;
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David Hubmayr
7Takeda, Zurich, Switzerland;
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Ferran Mirabent Rubinat
8Aizon, Carrer de Còrsega 301, 08008 Barcelona, Spain;
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Sandrine Dessoy
9Vaccines Technical Development, GSK, Rue De L′Institut 89, 1330 Rixensart, Walloon Brabant, Belgium; and
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Antonio Moreira
10Department of Chemical, Biochemical, and Environmental Engineering, University of Maryland Baltimore County, 1000 Hilltop Circle, Baltimore, MD 21250
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References

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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
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Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
Mario Stassen, Catarina S. Leitão, Toni Manzano, Francisco Valero, Benjamin Stevens, Matt Schmucki, David Hubmayr, Ferran Mirabent Rubinat, Sandrine Dessoy, Antonio Moreira
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 68-87; DOI: 10.5731/pdajpst.2024.012950

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Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
Mario Stassen, Catarina S. Leitão, Toni Manzano, Francisco Valero, Benjamin Stevens, Matt Schmucki, David Hubmayr, Ferran Mirabent Rubinat, Sandrine Dessoy, Antonio Moreira
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 68-87; DOI: 10.5731/pdajpst.2024.012950
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  • Article
    • Abstract
    • Preamble
    • Introduction
    • Background
    • Objectives
    • Project Justification
    • Research Methodology
    • Results
    • Discussion
    • Practical Guidance on AI in Manufacturing
    • Conclusion
    • Conflict of Interest Declaration
    • Disclaimer
    • Acknowledgements
    • Appendix 1 – Questionnaire
    • Appendix 2 - Issues, Comments and Recommendations from the Interviews
    • Appendix 3 - Positive Aspects Considered During Phase 1 of the Project
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