In-and-Out Characterization and CQA Monitoring
of AAVs with the Genedata Biopharma Platform

February 26, 2026

Discover how the Genedata Biopharma Platform streamlines in‑depth AAV CQA monitoring across mass spectrometry (MS) and next‑generation sequencing (NGS), enabling faster, safer, and more compliant AAV development from research through manufacturing.
 

Key Highlights:
•     Comprehensive AAV CQA Coverage — Supports identity, integrity, safety, impurity profiling, VP proteoforms, PTMs, genome quality, and adventitious agent detection, all within one harmonized ecosystem.

•     Integrated MS & NGS Analytics — Time‑resolved deconvolution for intact capsid proteins, automated peptide mapping, and in‑house NGS workflows for vector QC, contamination detection, fusion analysis, and biosafety testing.

•     Automation & Standardization Across Sites — Wizard‑based Playbooks eliminate manual steps, reduce errors, and ensure reproducible, regulatory‑compliant analyses across R&D, QC, and manufacturing.

•     GxP‑Ready Infrastructure — Includes audit trails, 21 CFR Part 11 capabilities, validation packages, and secure on‑prem or single‑tenant cloud deployment.

•     Enterprise‑Wide Digital Foundation — Unifies data, instruments, and workflows across USP, DSP, and QC, enabling faster timelines, higher data integrity, and reduced operational risk.