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

Anna S&amp;aumlrnef&amp;aumllt; Ranna Eardley-Patel; Diletta Magini; Vishal Sonje; Antonio Guzzi; Renske Hesselink; Matthew Scotney; Alessandro Lazdins; Valerie Chambard; Christof Vinnemeier; Ingrid Kromann

doi:10.5731/pdajpst.2023.012912

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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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ORCID record for Anna Särnefält
For correspondence: anna.sarnefalt@cepi.net

Ranna Eardley-Patel

CEPI

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For correspondence: ranna.eardley-patel@cepi.net

Diletta Magini

CEPI

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For correspondence: diletta.magini@cepi.net

Vishal Sonje

CEPI

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For correspondence: vishal.sonje@cepi.net

Antonio Guzzi

CEPI

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For correspondence: antonio.guzzi@cepi.net

Renske Hesselink

CEPI

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For correspondence: renske.hesselink@cepi.net

Matthew Scotney

CEPI

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For correspondence: matthew.scotney@cepi.net

Alessandro Lazdins

CEPI

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For correspondence: alessandro.lazdins@cepi.net

Valerie Chambard

CEPI

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For correspondence: valerie.chambard@cepi.net

Christof Vinnemeier

CEPI

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For correspondence: christof.vinnemeier@cepi.net

Ingrid Kromann

CEPI

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ORCID record for Ingrid Kromann
For correspondence: ingrid.kromann@cepi.net

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PDA Journal of Pharmaceutical Science and Technology

Vol. 78, Issue 4

July/August 2024

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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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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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Keywords

CMC
CTM
GMP
stage-appropriate CMC milestones
vaccine development
valleys of death

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Parenteral Drug Association, Inc.