Wyatt Technology Pioneers Multi-CQA Method for Gene Vectors
Product News Apr 08, 2020
Wyatt Technology, a company specializing 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.