Critical to enable meaningful comparisons between research studies and clinical trials, these well-characterized reference standards are extensively quality analyzed with molecular based assays and transmission electron microscope.
Gene therapy researchers have long expressed the importance of well characterized 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-characterized 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 characterized 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.