PATfix® - AAV Platform

The PATfix^® AAV Platform delivers a consolidated analytical workflow for adeno-associated virus downstream process development and quality control. Built on qualified chromatographic methods and multi-detector analytics, it enables rapid assessment from harvest to fill and finish with minimal sample preparation.

Four methods address the core analytical needs of AAV DSP: Impurities Detection uses size exclusion chromatography on BIA SEC Methacrylate‑2000A for qualitative monitoring of proteins, DNA/RNA, aggregates, and complexes. Total Viral Capsids employs cation exchange chromatography with CIMac SO3 for serotype-independent determination of total AAV capsids across AAV2, AAV5, AAV6, AAV8, and AAV9. Empty/Full Process Development with CIMac QA HR establishes baseline separation of empty and full capsids and scales from analytical to preparative work. AAV8 Product Purity provides precise quantification of full AAV8 capsids with LOQ at 1.5E+09 vg/mL, linearity from 5E+09 to 5E+10 vg/mL, and RSD < 15% per EMA and FDA guidelines.

The multi-detector configuration includes UV absorbance (190–700 nm), contactless conductivity and pH probes, plus optional fluorescence for protein signatures and host cell DNA analysis. Optional MALS selectively identifies AAV capsids and aggregates and supports recovery calculations. Hardware featuring a quaternary low-pressure gradient pump, autosampler for 108 vials (4–40°C), and column thermostat (5–85°C) ensures robust routine analytics.

PATfix^® software provides 21 CFR Part 11 compliance, templates for data extraction, and a unified database for chromatograms from multiple instruments. Methods and SOPs with buffer guidelines (WO2024252024A1, WO2025073922) reduce variability and standardize analysis starting at eight minutes per sample.

Orthogonal validations show close agreement with density gradient ultracentrifugation, TEM, CD‑MS, and dPCR/ELISA for AAV8 samples. By consolidating impurities detection, total capsid recovery, and empty/full analytics, this platform supports data-driven decisions in AAV process development. Request method details, SOPs, and application notes to integrate at‑line analytics into your DSP.