Table 2. Release requirements1 of plain and adjuvanted sIPV.
| Cell culture | ||
| Identity | Vero cells | |
| Mycoplasma | Absent | |
| Extraneous viruses | Absent | |
| Virus harvest | ||
| Sterility | Absence of growth (Tryptic Soy Broth & Thioglycollate broth) | |
| Mycoplasma | Absent | |
| Extraneous viruses | Absent | |
| Purified virus | ||
| Purity (ratio total protein and D-antigen) | ≤0.1 µg DU-1 | |
| Sterility | As above | |
| Identity | PV type 1, 2 OR 3 | |
| Residual host cell proteins | Consistent clearance | |
| Monovalent Bulk | ||
| Inactivation kinetics | PV titer below detection limit after 120h | |
| Formaldehyde | >2 mM | |
| Sterility | As above | |
| PV identity | Contains PV type 1, 2 OR 3 | |
| Inactivation | Full absence of active PV after 10 and 13 days | |
| D-antigen content | Information for calculation | |
| Trivalent bulk | ||
| Inactivation | Full absence of active PV in 1,500 calculated human doses | |
| Sterility | As above | |
| D-antigen content | Information for calculation | |
| Final bulk | Plain | Adjuvanted |
| pH | 6.8-7.4 | 6.8-7.4 |
| Phenoxyethanol | 31-42 mM | 31-42 mM |
| Formaldehyde 2 | 0.7-2.4 mM | 0.7-1.3 mM |
| Sterility | As above | As above |
| D-antigen content | ≥75% nominal value | ≥75% nominal value |
| Final lot | Plain | Adjuvanted |
| Appearance | Bright red-orange fluid | Turbid red-orange fluid |
| PV identity | Contains type PV 1, 2 and 3 | Contains type PV 1, 2 and 3 |
| D-antigen content | ≥75% nominal value | ≥75% nominal value |
| Residual host cell DNA 3 | ≤100 pg shd-1 | ≤100 pg shd-1 |
| Bovin Serum Albumin 3 | ≤50 ng shd-1 | ≤50 ng shd-1 |
| Total protein | ≤20 µg mL-1 | ≤20 µg mL-1 |
| Endotoxin | ≤10 IU mL-1 | ≤10 IU mL-1 |
| Extractable volume | ≥0.5 mL | ≥0.5 mL |
| pH | 6.8-7.4 | 6.8-7.4 |
| Sterility | As above | As above |
| Free D-antigen | Not applicable | < 1% |
| Aluminium | Not applicable | 0.26-0.36 mg mL-1 |
| Abnormal toxicity (in mice and guinea pigs) | No illness | No illness |
1 Most important release tests drafted for the production of the phase I clinical lots are given. It should be noted that the release criteria could change due to further product development. 2 Formaldehyde requirement is dependent on the amount of monovalent bulk used to prepare the final bulk. 3 Test is performed at an earlier stage in view of the lower detection limit.