Reference standards improve AAV production
Amsbio (Oxford, UK) announces a new range of well-characterized adeno-associated virus (AAV) reference standards that enable researchers to significantly improve their AAV production processes.
AAV 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 characterized 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 also 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 – as well as facilitates 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.
For further information please visit https://www.amsbio.com/aav-reference-standards/ or contact Amsbio on +31-72-8080244 / +44-1235-828200 / +1-617-945-5033 / [email protected].
About Amsbio
Now part of the Europa Biosite group of companies, AMS Biotechnology (Amsbio) is recognized as a leading transatlantic company contributing to the acceleration of discovery through the provision of cutting-edge life science technology, products and services for R&D in the medical, nutrition, cosmetics and energy industries. Amsbio has in-depth expertise in extracellular matrices (ECMs) to provide elegant solutions for studying cell motility, migration, invasion and proliferation. This expertise in cell culture and the ECM allows Amsbio to partner with clients in tailoring cell systems to enhance organoid and spheroid screening outcomes using a variety of 3D culture systems, including organ-on-a-chip microfluidics. For drug discovery research, Amsbio offers assays, recombinant proteins and cell lines. Drawing upon a huge and comprehensive biorepository, Amsbio is widely recognized as a leading provider of high-quality tissue specimens (including custom procurement) from both human and animal tissues. The company provides unique clinical-grade products for stem cells and cell therapy applications. This includes GMP cryopreservation technology and high-quality solutions for viral delivery.