A Robust and Automated Platform for Charge Detection Mass Spectrometry of Megadalton Biotherapeutics.

ABSTRACT: Gene therapies based on adeno-associated viruses are an emerging area with high potential to improve human health. Current quality control techniques to assess contaminates and byproducts from the adeno-associated virus (AAV) production pipelines are lacking in robustness and throughput. To address these limitations, we coupled an automated microfluidic device called SampleStream with Orbitrap-based charge detection mass spectrometry (SS-CDMS). We demonstrate that the SS-CDMS workflow performs AAV analysis in under 15 min per sample in a completely autonomous manner. The SS-CDMS workflow enables rapid assessment of key quality control attributes (CQAs), such as of molecular weight and content ratio of AAV formulations with a small sample requirement (<2 × 10⁹ capsids) without be

SUBMITTER: Janisse SE 

PROVIDER: S-EPMC12323853 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature