Product Quality Characterization for Process Utilizing Additional Virus Barriers (9). HTST Processing at 102 °C for 10 s; 2 L Scale Culture System
| Activity | Man-Phos (mol/mol) | Sialic Acid (mol/mol) | % Main Peak Monomer | |
|---|---|---|---|---|
| Control cultures (n = 5) | 0.94 ± 0.04 | 0.79 ± 0.04 | 1.9 ± 0.3 | 98.5 ± 0.2 |
| Viral barrier cultures (n = 5) | 0.96 ± 0.18 | 0.83 ± 0.03 | 1.8 ± 0.3 | 98.6 ± 0.4 |
| p-value | 0.83 | 0.11 | 0.78 | 0.63 |
Titer (103%), deamidation, IEF gels, peptide map, and oligosaccharide profiles also consistent.