Table 2.
Preparation of verification samples and their reference SEC-MALS and ELISA values
| Sample | SEC-MALS |
ELISA Titer (cp/mL × 1012) |
Sample composition |
|
|---|---|---|---|---|
| %Full | Titer (cp/mL × 1012) | Stock F; Stock E; Eluent A | ||
| Stock E | 0.0 | 7.2 | 10.0 | NA |
| Stock F | 46.9 | 8.4 | 10.0 | NA |
| V 01 | 46.9a | 6.1a | 7.3a | 0.73 F; 0.27 Eluent A |
| V 02 | 0.0a | 1.4a | 2.0a | 0.20 E; 0.80 Eluent A |
| V 03 | 13.1a | 6.3a | 8.4a | 0.21 F; 0.63 E; 0.16 Eluent A |
| V 04 | 36.5a | 4.8a | 6.0a | 0.45 F; 0.15 E; 0.39 Eluent A |
| V 05 | 25.3a | 3.3a | 4.2a | 0.21 F; 0.21 E; 0.58 Eluent A |
a
%Full and expected titers are calculated based on their mixing ratios and the respective analytical results for stocks E and F.