Guidance on the Characterisation of the particle population in AAV products

The quality of a medicine is critical to ensuring its safety and efficacy, and therefore the medicine’s suitability for patients. The use of analytical techniques is a vital component in the assurance of medicines quality.

Identified as a priority through stakeholder engagement following the release of the Medicines and Healthcare products Regulatory Agency’s Strategy for pharmacopoeial public quality standards for biological medicines, the British Pharmacopoeia (BP) has prepared draft authoritative, non-mandatory, best practice guidance on the Characterisation of the particle population in AAV products.

Written by experts, the BP believes the text will be helpful to a range of stakeholders including those operating in GMP regulated environments, research and development, academia and at clinical trials. The guidance is intended to ensure patient safety by providing an outline of best practices to ensure product quality is upheld throughout the product’s lifecycle.

This consultation closed on 31 January 2023.

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Strategy for pharmacopoeial public quality standards for biological medicines