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Wyatt Technology pioneers multi-CQA method for gene vectors

Waters | Wyatt Technology

AAV analysis determines titer, full:empty capsid ratio and aggregation in a single 30-minute run

19 Apr 2020
Georgina Wynne Hughes
Editorial Assistant

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Wyatt Technology, a world leader in instrumentation for absolute macromolecular and nanoparticle characterization, has announced the release of a novel method suitable for determining multiple critical quality attributes of adeno-associated virus and similar small gene vectors, in a single chromatographic run.

The method is based on SEC-MALS, which combines size-exclusion chromatography for separation with multi-angle light scattering for characterization. SEC-MALS was introduced by Wyatt in 1985 and has been a mainstay of biophysical characterization of biotherapeutics such as monoclonal antibodies and virus-like particles. It utilizes Wyatt’s DAWN® MALS instrument coupled to an industry-standard SEC system and offers full support for FDA 21CFR(11) compliance.

Critical quality attributes are the basic lot release specifications a biotherapeutic product must meet in order to ensure safety and efficacy. Typically, each CQA requires a separate assay, some of which can be laborious and time-consuming with relatively low reliability. The new SEC-MALS AAV analysis determines three CQAs: total capsid titer, the fraction of capsids without the requisite gene cargo, and the amount of aggregated viruses. All this is carried out in a single precise and automated measurement that takes just thirty minutes, enabling producers of these gene therapies to develop, market and supply these life-enhancing products faster and with greater confidence.

“This unique SEC-MALS AAV analysis provides great value to our customers in the gene therapy space.” says Michelle Chen, Ph.D., VP of Analytical Services at Wyatt Technology. “They have validated it against previous standard methods and found that it not only saves time and effort, but also provides more accurate and reliable results at lower cost. The triple-CQA AAV analysis method is a home run.”

Developing novel means for characterizing gene vectors is just one more way that Wyatt Technology fulfills its mission: to help ensure their customers’ success in providing leading-edge, life-enhancing products.

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DAWN™

Waters | Wyatt Technology

The DAWN is the premier Multi-Angle static Light Scattering (MALS) detector for absolute characterization of the molar mass and size of macromolecules and nanoparticles in solution, offering the highest sensitivity and widest range of molecular weight, size, concentration and optional features.

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Size Exclusion ChromatographySize exclusion chromatography (SEC) is a liquid chromatographic technique used to separate and identify molecules based on their size, including polymers, proteins, nanoparticles & nucleic acid. SEC is further subdivided into gel filtration chromatography (GFC) and gel permeation chromatography (GPC) when an aqueous or organic mobile phase is used respectively. HPLC-based SEC systems and columns are available for analytical separation alongside SEC spin columns or filters to prep samples for many protocols. Find the best size exclusion chromatography equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Monoclonal AntibodiesMonoclonal antibodies (mAbs) are lab-made molecules that can bind to specific antigens on cells, making them highly effective in treating cancers, autoimmune diseases, and infections. These targeted therapies are transforming the treatment landscape for many conditions. Browse our peer-reviewed product directory to find monoclonal antibodies for research and clinical applications; compare products, check reviews, and get pricing directly from manufacturers.ChromatographyChromatography is a powerful technique used to separate and analyze components of mixtures based on their chemical properties. It is widely used in fields like biochemistry, pharmaceuticals, and environmental analysis. By exploiting differences in the interaction of substances with a stationary phase and a mobile phase, chromatography enables precise purification and quantification of compounds. Whether you're working with complex biological samples or industrial chemicals, chromatography is essential for obtaining high-quality results. Browse our peer-reviewed product directory to find the best chromatography systems, compare products, read customer reviews, and get pricing directly from manufacturers.BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in <i>in vivo</i> diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.VirusesViruses are microscopic pathogens that require a host cell to replicate. Understanding their structure, replication cycle, and impact on the immune system is crucial in developing effective treatments, vaccines, and diagnostic methods. Research continues to focus on emerging viral diseases and antiviral drug discovery. Explore solutions for virus research, detection, and treatment in our peer-reviewed product directory; compare products, check customer reviews, and get pricing directly from manufacturers.SECSize exclusion chromatography (SEC) separates molecules based on size, ideal for protein purification, polymer analysis, and biopharma applications. SEC ensures precise characterization of biomolecules for research and industry. Explore peer-reviewed SEC products and compare options for your lab.NanoparticlesNanoparticles are between 1-100nm in size. Nanoparticles can be used for a wide variety of applications including biomedical, catalysis and electronics.Gene TherapyGene therapy is a technique that modifies or replaces genes within an individual's cells to treat or prevent diseases. This approach holds potential for curing genetic disorders, cancers, and certain viral infections. Advances in gene editing technologies like CRISPR are driving the growth of gene therapy. Explore gene therapy tools and technologies in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.

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