Hua Yang

A look at the LC and LC–MS methods that are helping to overcome challenges in sample analysis, and how this can make adeno‑associated virus (AAV)–based gene therapy more accessible.

Recombinant adeno-associated viral therapy (rAAV) products are particularly complex. Are liquid chromatography and LC–MS the right tools for their characterization?

The single-stranded DNA (ssDNA) content of AAV capsids in AAV-based gene therapy preparations impacts the efficacy of this treatment modality. We demonstrate that AAV8 capsids without and with full length ssDNA can be separated and their relative abundances determined on a Waters Protein-Pak Hi Res Q strong anion-exchange column.

A surge in the development and commercialization of monoclonal antibody (mAb)-based ther-apeutics has driven the requirement for accurate and reproducible analytical methods for pro-tein characterization. Monoclonal antibodies are popular biologic drug candidates, but are sus-ceptible to a myriad of modifications during manufacture and complex degradation pathways during purification and storage, often leading to distinct charge variants that require character-ization and quantification. Ion‑exchange liquid chromatography (IEX) is a well-accepted and widely used technique to separate various mAb charge variant species for the sake of charac-terization and profiling. With the most recent advances in analytical technologies, IEX can be used to help ensure the selection of stable and efficacious mAb drug candidates, from discov-ery through manufacturing.