Guidance on the application of flow cytometry for the cell and gene therapy community

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. Flow cytometry is a widely used technique in the development and testing of cell and gene therapy products, which have the potential to be transformative to patients and healthcare globally. 

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 application of flow cytometry. 

Written by experts in the flow cytometry community for the flow cytometry community, the BP believes the text will be helpful to a range of stakeholders including those operating in GMP regulated environments, research and development, and 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.

The consultation ran from 14 April 2021 to 19 May 2021 and a response was published on 20 August 2021.

The consultation response document can be found here