Flow Chart of Samples for the Low-pH Viral Inactivation Study
| Sample Number | Sample Name | Control | Low-pH Treatment | Purpose |
|---|---|---|---|---|
| 1 | Spiking virus (may also be the titration assay positive control) | Spiking virus | Determines if the assay is performing as expected | |
| 2 | Medium control, T = 0 | Cell culture medium spiked with virus (T = 0) | Provides information on the expected virus titer without the process pool at T = 0 | |
| 3 | Process control, T = 0 | Neutralized low-pH process pool spiked with virus (T = 0) | Provides the expected virus titer in the presence of the process pool at T = 0 | |
| 4 | Low-pH pool, T = 0 | Low-pH process pool, spiked with virus (T = 0) | Provides information if immediate inactivation of virus occurs in the process pool low-pH conditions | |
| 5 | Low-pH pool, T = intermediate time 1 | Low-pH process pool, spiked with virus (T = intermediate time 1) | Virus out sample | |
| 6 | Low-pH pool, T = intermediate time 2 | Low-pH process pool, spiked with virus (T = intermediate time 2) | Virus out sample | |
| 7 | Low-pH pool, T = end time | Low-pH process pool, spiked with virus (T = end time) | Virus out sample | |
| 8 | Medium control, T = end time | Cell culture medium spiked with virus (T = end time) | Provides information on the stability of the virus throughout the inactivation procedure | |
| 9 | Process control, T = end time | Neutralized low-pH process pool spiked with virus (T = end time) | Load or virus in sample. Also, provides information on the stability of the virus in the presence of the process pool throughout the inactivation procedure |