Smart Practices for production of challenge agents

The Smart Practices are a summary of the “Considerations on the principles of development and manufacturing qualities of challenge agents for use in human infection models”, a document developed by a consortium of international experts to discuss fundamental principles of selection, characterisation, manufacture, quality control and storage of challenge agents for international reference.

They do not form regulatory guidelines or guidance but reflect the consortium’s recommendations in the absence of clear regulatory guidance.

The core principles summarised in this document encompass:

Challenge agent characteristics and clinical study design
Engagement with regulatory bodies
Selecting and characterising challenge agent, with reference to desired study objectives
Production considerations, including; equipment/reagents, personnel, facilities, documentation, environmental monitoring, and shipping/transportation.
QC and testing (identity, purity, potency and stability)
Storage and monitoring long-term challenge agent stability
Keeping a challenge agent dossier

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