Rapid At-Line AAVX Affinity HPLC: Enabling Process Analytical Technology for Bioprocess Development of Adeno-Associated Virus Vectors.

ABSTRACT: Recombinant adeno-associated virus (rAAV) vectors have emerged as a new class of therapeutic modal with the promise to treat or even cure hereditary and acquired diseases, but their consistent and efficient production remains challenging. To address these inadequacies, the implementation of process analytical technology (PAT) principles for the development of rAAV-based gene therapies holds the prospect of promoting greater product and process understanding. However, a substantial lack of suitable analytical tools during both upstream and downstream processing (DSP) hinders the ability to fully realize the potential of PAT for rAAVs. To fill this gap, our recently described AAVX affinity-based high-performance liquid chromatography (HPLC) method was assessed as an at-line PAT tool to deter

SUBMITTER: Heckel J 

PROVIDER: S-EPMC11917522 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature