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.