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NIBSC – Physical Standards for Adeno-associated virus (AAV) Gene Therapy – Regulators Pioneer Funded Project 2021-2022

The project outlines that Gene therapy is a transformational technology that promises new innovative medicines to prevent or treat inheritable diseases and those associated with aging.

In vivo gene therapy using Adeno-associated Virus (AAV) vectors is one of the fastest growing sectors of the gene therapy market. With this increase there will be a requirement for increased regulation of products. To assure rapid authorisation and availability of new life-changing medicines requires fast and robust mechanisms for comparing products, which biological standardisation can provide.

The AAV vector community currently relies upon AAV reference material produced over a decade ago and this supply is rapidly depleting. To address the challenge faced globally by this sector, scientists specialising in biological standards and control at the Medicines and Healthcare products Regulatory Agency (MHRA) and the Cell and Gene Therapy Catapult (CGT Catapult) have demonstrated, through manufacture and coordinated analysis at multiple international centres, that there is a requirement for development in the field of AAV associated standards.

During this 6-month project colleagues at the CGTC and MHRA have worked together to manufacture and characterise an AAV reference material for coordinated analysis at multiple centres.

See the full news report here and read the entirety of the project outline. Published on the 11th of October 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (30 novembre 2022). NIBSC – Physical Standards for Adeno-associated virus (AAV) Gene Therapy – Regulators Pioneer Funded Project 2021-2022. ELSIBI. Consulté le 17 février 2026 à l’adresse https://doi.org/10.58079/o65s


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