How Important are AAV Reference Materials in Gene Therapy?

AMSBIO has announced a new range of AAV reference materials of full capsids and empty capsids of 6 different serotypes. 

Critical to enable meaningful comparisons between research studies and clinical trials, these well-characterised reference standards are extensively quality analysed with molecular based assays and transmission electron microscope.

Gene therapy researchers have long expressed the importance of well characterised AAV reference materials. Recombinant adeno-associated virus (rAAV) is a widely used gene delivery tool for research and clinical applications. Following the US Federal Drug Administration gene therapy CMC guidance published in January 2020, commercially sourced, well-characterised AAV reference materials are one of the cited reference materials for gene therapy.  

AMSBIO’s AAV reference materials (full capsids) with accurate vector genome concentration can be used in qPCR-based vector genome quantification. Additionally, these AAV reference materials are well characterised for full-to-empty capsid ratio.  AAV reference materials are available from Amsbio in AAV1, AAV2, AAV5, AAV6, AAV8 and AAV9 serotypes. 

Adeno-Associated Virus are also known to produce empty particles without payloads. These high purity, quality certified AAV empty capsids reference materials can be used as controls and standards in assays, including HPLC and ELISA, AMSBIO offer these AAV empty capsid reference materials in AAV1, AAV2, AAV5, AAV6, AAV8 and AAV9 serotypes.

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