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EDQM – OMCL Gene Therapy Working Group Study Published (from Catapult’s regulatory round-up – October 2023)

The GT005 project was initiated by the Gene Therapy Working Group (GTWG) of the GEON (General European OMCL Network), coordinated by the EDQM, with the aim of validating a method that could be broadly used for the quantification of vector genomes within AAV2- based gene therapy products. The results of this study have been published online in Pharmeuropa Bio & Scientific Notes. The article, entitled “Validation of a qPCR method for determination of viral genome titres of AAV2-based vector preparations”, describes the project which makes way for promising steps to standardisation of analytical methods for the quality control of gene therapy products.

Published on the 6th of november 2023. Read the entire regulatory round-up here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (21 mai 2024). EDQM – OMCL Gene Therapy Working Group Study Published (from Catapult’s regulatory round-up – October 2023). ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/11ozq


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