Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain

  1. Bekeredjian-Ding, Isabelle ORCID logo
  2. Trouvin, Jean-Hugues
  3. Depraetere, Hilde
  4. La, Carine
  5. Suvarnapunya, Akamol E.
  6. Bell, Alan
  7. Mann, Alex
  8. Meij, Pauline
  9. Bethony, Jeffrey M.
  10. Schellhaas, Linda
  11. Nazziwa, Winfred Badanga
  12. Karikari-Boateng, Eric
  13. Prachumsri, Jetsumon Sattabongkot
  14. Salmikangas, Paula
  15. Smith, Dean
  16. Stjärnkvist, Peter
  17. van Molle, Wim
  18. Baay, Marc
  19. Neels, Pieter

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1000 Titel
  • Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain
1000 Autor/in
  1. Bekeredjian-Ding, Isabelle |
  2. Trouvin, Jean-Hugues |
  3. Depraetere, Hilde |
  4. La, Carine |
  5. Suvarnapunya, Akamol E. |
  6. Bell, Alan |
  7. Mann, Alex |
  8. Meij, Pauline |
  9. Bethony, Jeffrey M. |
  10. Schellhaas, Linda |
  11. Nazziwa, Winfred Badanga |
  12. Karikari-Boateng, Eric |
  13. Prachumsri, Jetsumon Sattabongkot |
  14. Salmikangas, Paula |
  15. Smith, Dean |
  16. Stjärnkvist, Peter |
  17. van Molle, Wim |
  18. Baay, Marc |
  19. Neels, Pieter |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-10-05
1000 Erschienen in
1000 Quellenangabe
  • 74:16-23
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1016/j.biologicals.2021.09.002 |
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  • There is an increasing need to establish quality principles for designing, developing and manufacturing challenge agents as currently these agents are classified differently by various jurisdictions. Indeed, considerations for challenge agent manufacturing vary between countries due to differences in regulatory oversight, the categorization of the challenge agent and incorporation into medicinal/vaccine development processes. To this end, a whitepaper on the guidance has been produced and disseminated for consultation to researchers, regulatory experts and regulatory or advisory bodies. This document is intended to discuss fundamental principles of selection, characterization, manufacture, quality control and storage of challenge agents for international reference. In the development phase, CMC documentation is needed for a candidate challenge agent, while standard operating procedure documentation is needed to monitor and control the manufacturing process, followed by use of qualified methods to test critical steps in the manufacturing process, or the final product itself. These activities are complementary: GMP rules, which intervene only at the time of the routine manufacturing of batches, do not contribute to the proper development and qualification of the candidate product. Some considerations regarding suitability of premises for challenge manufacturing was discussed in the presentation dedicated to "routine manufacturing".
1000 Sacherschließung
lokal CMC
lokal GMP
lokal Challenge agents
lokal Regulatory
gnd 4437717-4 Arzneimittelüberwachung
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