Table 7.
The overall reduction factor of the manufacturing process
| Reduction factor of model viruses in the viral clearance process | Average Reduction Factors | ||||
|---|---|---|---|---|---|
|
| |||||
| HSV1 | VSV | EMCV | Reovirus | ||
| 5.49 | 4.37 | 3.12 | 3.52 | 4.06 | |
| Low pH Treatment | TCID50 : 3.58 | TCID50 : 3.70 | TCID50 : 4.75 | TCID50: 3.58 | TCID50: 3.90 |
| Chromatography | qPCR: 2.89 | qPCR: 2.48 | qPCR: 2.71 | qPCR: 2.89 | qPCR: 2.74 |
| (Cation Exchange) | TCID50: 4.25 | TCID50: 4.75 | TCID50: 5.25 | TCID50: 4.00 | TCID50 : 4.56 |
| Chromatography (Affinity) | qPCR: 2.97 | qPCR: 2.94 | qPCR: 2.91 | qPCR: 2.81 | qPCR: 2.90 |
| Nanofiltration | TCID50: 6.00 | TCID50: 7.00 | TCID50: 8.00 | TCID50: 6.00 | TCID50: 6.75 |
| Cumulative Reduction Factors | qPCR: 6.18 | qPCR: 7.00 | qPCR: 8.05 | qPCR: 6.09 | qPCR: 6.83 |
| TCID50: 19.32 | TCID50: 19.82 | TCID50: 21.12 | TCID50:17.10 | N.A. | |
| qPCR: 12.04 | qPCR: 12.42 | qPCR: 13.67 | qPCR: 11.79 | ||