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Research ArticlePDA Paper

Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management

Cristiana Campa, Didier ClÉnet, Jane Halpern, Lyne Le Palaire, Mahesh Krishnan, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt and Sabrina Restrepo
PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 735-750; DOI: https://doi.org/10.5731/pdajpst.2024.012976
Cristiana Campa
1GSK
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Didier ClÉnet
2Sanofi
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Jane Halpern
3IAVI
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Lyne Le Palaire
2Sanofi
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Mahesh Krishnan
4Merck & Co., Inc
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Mic McGoldrick
4Merck & Co., Inc
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Mihai Bilanin
1GSK
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Priyabrata Pattnaik
5Indian Immunologicals Ltd
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Richard Pelt
6Pfizer
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Sabrina Restrepo
4Merck & Co., Inc
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  • For correspondence: sabrina_restrepo@merck.com
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Article Information

vol. 78 no. 6 735-750
DOI 
https://doi.org/10.5731/pdajpst.2024.012976
PubMed 
39317640

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 26, 2024.

Article Versions

  • previous version (September 24, 2024 - 10:01).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2024

Author Information

  1. Cristiana Campa1,
  2. Didier ClÉnet2,
  3. Jane Halpern3,
  4. Lyne Le Palaire2,
  5. Mahesh Krishnan4,
  6. Mic McGoldrick4,
  7. Mihai Bilanin1,
  8. Priyabrata Pattnaik5,
  9. Richard Pelt6 and
  10. Sabrina Restrepo4,*
  1. 1GSK
  2. 2Sanofi
  3. 3IAVI
  4. 4Merck & Co., Inc
  5. 5Indian Immunologicals Ltd
  6. 6Pfizer
  1. ↵* Corresponding Author: Merck Sharpe & Dohme LLC, Rahway, NJ; E-mail: sabrina_restrepo{at}merck.com
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PDA Journal of Pharmaceutical Science and Technology: 78 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 6
November/December 2024
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Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management
Cristiana Campa, Didier ClÉnet, Jane Halpern, Lyne Le Palaire, Mahesh Krishnan, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt, Sabrina Restrepo
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 735-750; DOI: 10.5731/pdajpst.2024.012976

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Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management
Cristiana Campa, Didier ClÉnet, Jane Halpern, Lyne Le Palaire, Mahesh Krishnan, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt, Sabrina Restrepo
PDA Journal of Pharmaceutical Science and Technology Nov 2024, 78 (6) 735-750; DOI: 10.5731/pdajpst.2024.012976
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Keywords

  • Post-approval changes
  • Life cycle management
  • Vaccines
  • Cell bank
  • Raw materials
  • Platform
  • Potency
  • Technology transfer

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