Amsbio announces a new range of well characterized Adeno-Associated Virus (AAV) reference standards that enable researchers to significantly improve their AAV production processes.

Adeno-associated virus can be engineered to transport DNA of interest to target cells, without any viral genes - making them a highly desirable and safe tool for gene therapy. However, one of the greatest challenges in AAV production is that AAV preparations contain a considerable number of viral particles without gene payloads. Even after purification procedures, samples include empty capsids. In gene therapy applications, the reliability and accuracy of research depend significantly on the use of high-quality reference materials.

The highly characterised and well-defined reference standards available from Amsbio are essential for quantitative AAV production. These thoroughly analyzed particles offer precise titers and well-defined full-to-empty capsid ratios. Their comprehensive characterization is vital for standardizing measurements, ensuring consistency across experiments, and providing reliable data for gene therapy applications and other research involving AAV vectors.

Amsbio offers two types of AAV reference materials – full and empty for a wide range of serotypes. Full AAV reference standards are essential, well-characterized materials used in gene therapy to calibrate qPCR and ELISA assays, ensure consistency across labs, validate testing methods, and establish benchmarks for critical quality attributes (CQAs). Their use helps to guarantee the safety, quality, and comparability of AAV gene therapy products from research to clinical use, particularly for determining vector genome concentration and the full-to-empty capsid ratio.

Empty AAV reference standards are crucial for gene therapy development and manufacturing, serving as benchmarks to quantify the percentage of "full" versus "empty" viral capsids in production batches. Their use helps ensure product quality, safety, and consistency by calibrating analytical methods like qPCR, HPLC, and ELISA, and assessment of immunogenicity and biodistribution.

Each AAV reference standard supplied by Amsbio undergoes extensive characterization, including ddPCR, ELISA, silver staining, mass photometry, and full safety testing for bioburden, mycoplasma, and endotoxin. The reported quantification data for each AAV reference standard is traceable to ATCC Reference Standard Material, providing confidence and consistency for gene therapy development, QC, and regulatory workflows.