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OtherPDA 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 Clenet, Jane Halpern, Lyne Le Palaire, Mahesh Krishna, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt and Sabrina Restrepo
PDA Journal of Pharmaceutical Science and Technology September 2024, pdajpst.2024.012976; DOI: https://doi.org/10.5731/pdajpst.2024.012976
Cristiana Campa
1 GSK Vaccines;
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  • For correspondence: cristiana.x.campa@gsk.com
Didier Clenet
2 Sanofi Pasteur;
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  • For correspondence: didier.clenet@sanofi.com
Jane Halpern
3 International AIDS Vaccine Initiative (IAVI);
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  • For correspondence: jhalpern@iavi.org
Lyne Le Palaire
2 Sanofi Pasteur;
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  • For correspondence: lyne.lepalaire@sanofi.com
Mahesh Krishna
4 Merck Sharpe & Dohme LLC;
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  • For correspondence: mahesh_krishnan@merck.com
Mic McGoldrick
4 Merck Sharpe & Dohme LLC;
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  • For correspondence: mic_mcgoldrick@merck.com
Mihai Bilanin
1 GSK Vaccines;
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Priyabrata Pattnaik
5 Indian Immunologicals Limited;
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  • For correspondence: p.pattnaik@indimmune.com
Richard Pelt
6 Pfizer Inc.
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  • For correspondence: rich.peltii@pfizer.com
Sabrina Restrepo
4 Merck Sharpe & Dohme LLC;
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  • For correspondence: sabrina_restrepo@merck.com
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Article Information

pdajpst.2024.012976
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 
  • Received June 6, 2024
  • Accepted August 28, 2024
  • Published online September 24, 2024.

Article Versions

  • You are currently viewing a previous version of this article (September 24, 2024 - 10:01).
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Copyright & Usage 
Copyright © 2024, Parenteral Drug Association

Author Information

  1. Cristiana Campa1 (cristiana.x.campa@gsk.com),
  2. Didier Clenet2 (didier.clenet@sanofi.com),
  3. Jane Halpern3 (jhalpern@iavi.org),
  4. Lyne Le Palaire2 (lyne.lepalaire@sanofi.com),
  5. Mahesh Krishna4 (mahesh_krishnan@merck.com),
  6. Mic McGoldrick4 (mic_mcgoldrick@merck.com),
  7. Mihai Bilanin1,
  8. Priyabrata Pattnaik5 (p.pattnaik@indimmune.com),
  9. Richard Pelt6 (rich.peltii@pfizer.com) and
  10. Sabrina Restrepo4,7 (sabrina_restrepo@merck.com)
  1. 1 GSK Vaccines;
  2. 2 Sanofi Pasteur;
  3. 3 International AIDS Vaccine Initiative (IAVI);
  4. 4 Merck Sharpe & Dohme LLC;
  5. 5 Indian Immunologicals Limited;
  6. 6 Pfizer Inc.
  1. ↵* Corresponding author; email: sabrina_restrepo@merck.com

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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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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 Clenet, Jane Halpern, Lyne Le Palaire, Mahesh Krishna, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt, Sabrina Restrepo
PDA Journal of Pharmaceutical Science and Technology Sep 2024, pdajpst.2024.012976; DOI: 10.5731/pdajpst.2024.012976
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  • Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
  • Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
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Keywords

  • Post-approval changes
  • lifecycle management
  • Potency
  • raw materials, platform
  • Technology transfer
  • vaccines, cell bank

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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 Clenet, Jane Halpern, Lyne Le Palaire, Mahesh Krishna, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt, Sabrina Restrepo
PDA Journal of Pharmaceutical Science and Technology Sep 2024, pdajpst.2024.012976; DOI: 10.5731/pdajpst.2024.012976

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