Consultation for Characterisation of the Capsid Particle Population in rAAV Products: Determination of Vector Genome Identity, Integrity and Encapsidated DNA Impurities + Capsid Protein Characterisation
The British Pharmacopoeia (BP) has prepared two draft guidance documents:
2. Characterisation of the Capsid Particle Population in rAAV Products: Capsid Protein Characterisation.
These guidance documents, written by experts, will be helpful to a range of stakeholders including those in GMP regulated environments, research and development, academia, and clinical trials.
We would like your feedback on the guidance and validation plans from an individual standpoint as well as from your organisation’s standpoint – whichever is more appropriate. Your feedback will be used to improve the documents prior to their formal publication.
The response forms can be found here:
1. Consultation response for Determination of Vector Genome Identity, Integrity and Encapsidated DNA Impurities;
2. Consultation response for Capsid Protein Characterisation.
Completed response forms should be returned to BiolStandards@mhra.gov.uk by 27 March 2026.