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

Issued Date

2021-11-01

Resource Type

Article

ISSN

10958320
10451056

DOI

10.1016/j.biologicals.2021.09.002

Other identifier(s)

2-s2.0-85119924588

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Biologicals. Vol.74, (2021), 16-23

Suggested Citation

Isabelle Bekeredjian-Ding, Jean Hugues Trouvin, Hilde Depraetere, Carine La, Akamol E. Suvarnapunya, Alan Bell, Alex Mann, Pauline Meij, Jeffrey M. Bethony, Linda Schellhaas, Winfred Badanga Nazziwa, Eric Karikari-Boateng, Jetsumon Sattabongkot Prachumsri, Paula Salmikangas, Dean Smith, Peter Stjärnkvist, Wim Van Molle, Marc Baay, Pieter Neels Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain. Biologicals. Vol.74, (2021), 16-23. doi:10.1016/j.biologicals.2021.09.002 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/75968

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Title

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

Author(s)

Isabelle Bekeredjian-Ding
 Jean Hugues Trouvin
 Hilde Depraetere
 Carine La
 Akamol E. Suvarnapunya
 Alan Bell
 Alex Mann
 Pauline Meij
 Jeffrey M. Bethony
 Linda Schellhaas
 Winfred Badanga Nazziwa
 Eric Karikari-Boateng
 Jetsumon Sattabongkot Prachumsri
 Paula Salmikangas
 Dean Smith
 Peter Stjärnkvist
 Wim Van Molle
 Marc Baay
 Pieter Neels

Other Contributor(s)

hVIVO Services Limited
 Faculty of Tropical Medicine, Mahidol University
 P95 CVBA
 Paul-Ehrlich-Institut
 Health Canada
 Leids Universitair Medisch Centrum
 Walter Reed Army Institute of Research
 The George Washington University
 Medical Product Agency Sweden
 NDA Advisory Board
 Sciensano
 International Alliance for Biological Standardization
 Food and Drugs Authority
 European Vaccine Initiative
 Uganda National Council for Science and Technology

Abstract

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”.

Keyword(s)

Biochemistry, Genetics and Molecular Biology
 Chemical Engineering
 Immunology and Microbiology
 Pharmacology, Toxicology and Pharmaceutics

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/75968

Collections

Scopus 2021