| pH |
6.0–8.0 |
pH test (EP6) |
7.0 (conform)
|
| Pyrogenicity |
≤1.15°C temperature rise |
Intravenous injection in 3 rabbits (EP6) |
0.5°C (conform)
|
| Sterility |
Sterile |
Membrane filtration method (EP6) |
Sterile (conform)
|
| Cytotoxicity |
No cytotoxicity, no growth inhibition, no morphology changes |
Co-culture with human keratinocytes |
No cytotoxicity (conform), no growth inhibition (conform), no morphology changes (conform)
|
| Activity (titre) |
log(8)–log(10) pfu/ml |
Bacteriophage titration |
8 log(8)–log(9) pfu/ml (conform)
|
| Morphology of the bacteriophages |
2 Myoviridae and 1 Podoviridae
|
Transmission electron microscopy |
2 Myoviridae and 1 Podoviridae
(conform)
|
| Recognition of targeted bacteria |
Specific recognition |
Transmission electron microscopy |
One Myo- and one Podoviridae member recognize and kill P. aeruginosa. The other Myoviridae member recognizes and kills S. aureus
(conform)
|
| Phage intactness Absence of cellular debris |
Intact, pure |
Transmission electron microscopy |
Pure (conform)
|
| Temperate bacteriophages in host strains |
Total absence |
Mitomycin C induction of temperate bacteriophages |
Total absence (conform)
|
| Lytic nature |
Lytic |
DNA sequence and proteome analysis |
Lytic (conform)
|
| Presence of toxic proteins |
No toxic proteins |
DNA sequence and proteome analysis |
No predicted toxic proteins (conform)
|
