British Pharmacopoeia (BP) – New Advanced Therapy Medicinal Products Guidance : Characterisation of the Capsid Particle Population in rAAV Products (From Catapult’s regulatory round-up – January 2024)
This new guidance document addresses the use of methods for the standardisation of vector capsid particles in rAAV-based therapies and will provide current best practices. It aims to promote the standardisation of the currently established methods within the cell and gene therapy community. This document has been created to be read in conjunction with applicable guidance for method development and validation. The document can be downloaded here.
News Published on the 6th of february 2024. Read the entire regulatory round-up for January following this link.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (7 août 2024). British Pharmacopoeia (BP) – New Advanced Therapy Medicinal Products Guidance : Characterisation of the Capsid Particle Population in rAAV Products (From Catapult’s regulatory round-up – January 2024). ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/1258u
