Guidance on the application of vector copy number quantification for the ATMP 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. Vector copy number quantification is a widely used analytical technique in the development and testing of 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 vector copy number quantification for the cell and gene therapy community. Part I: Adeno-associated virus. Part II: Lentivirus and Retrovirus.
The consultation ran from 22 July 2021 to 27 September 2021 and a response was published on 23 March 2022.