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

• Tác giả: Kyle P Bowen, Philip D Compton, Kenneth R Durbin, Ryan T Fellers, Michael P Goodwin, Samuel E Janisse, Jared O Kafader, Neil L Kelleher, Zhirui J Lian, Shannon A Raab, Michael W Senko
• Ngôn ngữ: eng
• Thông tin xuất bản: United States : Analytical chemistry , 2025
• Bộ sưu tập: NCBI
• ID: 209215

Tóm tắt

 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 × 10