EDQM Collaborative study on validation of an ELISA method for determination of physical particle titre of AAV2 vectors: outcome published (from Catapult's regulatory round-up for December 2024)

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. Published on the 9th of ...