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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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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For correspondence: ingrid.kromann@cepi.net

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Article Information

pdajpst.2023.012912

DOI

https://doi.org/10.5731/pdajpst.2023.012912

PubMed

39054065

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received October 10, 2023
Accepted July 11, 2024
Published online July 25, 2024.

Author Information

Anna S&aumlrnef&aumllt 1 (anna.sarnefalt{at}cepi.net),
Ranna Eardley-Patel (ranna.eardley-patel{at}cepi.net),
Diletta Magini (diletta.magini{at}cepi.net),
Vishal Sonje (vishal.sonje{at}cepi.net),
Antonio Guzzi (antonio.guzzi{at}cepi.net),
Renske Hesselink (renske.hesselink{at}cepi.net),
Matthew Scotney (matthew.scotney{at}cepi.net),
Alessandro Lazdins (alessandro.lazdins{at}cepi.net),
Valerie Chambard (valerie.chambard{at}cepi.net),
Christof Vinnemeier (christof.vinnemeier{at}cepi.net) and
Ingrid Kromann (ingrid.kromann{at}cepi.net)

CEPI

↵* Corresponding author; email: anna.sarnefalt{at}cepi.net

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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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