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

Last updated on 10-2-2022 by Wim Van Molle

Peer reviewed scientific article





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. Thi…

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