Guidance on T cell and NK cell characterisation assays
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 T cell and NK cell characterisation assays.
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.
We would like your feedback on the guidance both from an individual standpoint as well as from your organisation’s standpoint – whichever is more appropriate. Your feedback will be used to improve the guidance prior to its formal publication.
Click here to download the consultation document, including background and the draft guidance.
Click here to download the consultation response form.
Completed response forms should be returned to BiolStandards@mhra.gov.uk by 31 May 2023 (deadline extended).