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OtherCommentary

A Strategic Guide to Improve and De-risk Vaccine Development: CEPI′s CMC Framework

Anna Särnefält, Ranna Eardley-Patel, Diletta Magini, Vishal Sonje, Antonio Guzzi, Renske Hesselink, Matthew Scotney, Alessandro Lazdins, Valerie Chambard, Christof Vinnemeier and Ingrid Kromann
PDA Journal of Pharmaceutical Science and Technology July 2024, pdajpst.2023.012912; DOI: https://doi.org/10.5731/pdajpst.2023.012912
Anna Särnefält
CEPI
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Ranna Eardley-Patel
CEPI
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Diletta Magini
CEPI
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Vishal Sonje
CEPI
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Antonio Guzzi
CEPI
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Renske Hesselink
CEPI
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Matthew Scotney
CEPI
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Alessandro Lazdins
CEPI
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Valerie Chambard
CEPI
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Christof Vinnemeier
CEPI
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Ingrid Kromann
CEPI
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  • For correspondence: ingrid.kromann@cepi.net
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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
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A Strategic Guide to Improve and De-risk Vaccine Development: CEPI′s CMC Framework
Anna S&aumlrnef&aumllt, Ranna Eardley-Patel, Diletta Magini, Vishal Sonje, Antonio Guzzi, Renske Hesselink, Matthew Scotney, Alessandro Lazdins, Valerie Chambard, Christof Vinnemeier, Ingrid Kromann
PDA Journal of Pharmaceutical Science and Technology Jul 2024, pdajpst.2023.012912; DOI: 10.5731/pdajpst.2023.012912
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More in this TOC Section

  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration—Post ICH Q5A(R2) Review
  • A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters
  • Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
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Keywords

  • CMC
  • CTM
  • GMP
  • Stage-appropriate CMC milestones
  • Vaccine development
  • Valleys of death

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A Strategic Guide to Improve and De-risk Vaccine Development: CEPI′s CMC Framework
Anna S&aumlrnef&aumllt, Ranna Eardley-Patel, Diletta Magini, Vishal Sonje, Antonio Guzzi, Renske Hesselink, Matthew Scotney, Alessandro Lazdins, Valerie Chambard, Christof Vinnemeier, Ingrid Kromann
PDA Journal of Pharmaceutical Science and Technology Jul 2024, pdajpst.2023.012912; DOI: 10.5731/pdajpst.2023.012912

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