SANTA BARBARA, CA — Wyatt Technology, the world leader in instrumentation for absolute macromolecular and nanoparticle characterization, announces 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, PhD, 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 our customers’ success in providing leading-edge, life-enhancing products.
Additional information on these ground-breaking instruments can be found at https://www.wyatt.com/GeneTherapy.