Early Stage Qualification Of Assays: Extending the Development Of iCIEF-Western Method From Mab to AAV to Support Extended Characterization

Time: 4:45 pm
day: Day Two


  • How to select assays that will be futureproof and support robust comparability analysis.
  • How to define release specification criteria that will support reproducibility of results late stage.
  • Discuss the analytical methods to support extended characterization:
    • CE-Western (Size-based) and iCIEF-Western (charge-based) are both developed in Regeneron to support mAb size and charge variants in comparability studies.
    • AAV anti-individual VP protein antibodies were developed to apply iCIEF-Western to AAV extended characterization.
    • Specific anti-individual VP protein antibodies detection provides identification and quantitation to assess each individual VP protein charge heterogeneity.