Back Collaborative study on validation of an ELISA method for determination of physical particle titre of AAV2 vectors: outcome published

EDQM Strasbourg, France 05/12/2024
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Collaborative study on validation of an ELISA method for determination of physical particle titre of AAV2 vectors: outcome published

The Gene Therapy Working Group (GTWG) of the General European Official Medicines Control Laboratory (OMCL) Network (GEON) organises collaborative studies to validate analytical methods for the quality control of gene therapy products.

A recent study focused on the validation of an ELISA method for the determination of the physical particle titre of AAV2-based vector preparations. The outcome of this study is now available online in Pharmeuropa Bio & Scientific Notes.

The GTWG was created in 2008 and is comprised of 11 national control laboratories that work together to prepare the OMCL Network for their surveillance role in this field.

Pharmeuropa Bio & Scientific Notes is published by the EDQM and referenced on Medline.