Virus and other safety tests of the M35-1 imMKCL MCB
| Item . | Method . | Criterion . | Result . |
|---|---|---|---|
| 1. Sterility test (bacteria and fungus) | Direct culture (JP, USP, and EP compatible) | Negative | Negative |
| 2. Mycoplasma test | Agar and nonagar culture (JP, USP, and EP compatible) | Negative | Negative |
| 3. Virus tests | |||
| General in vitro test | 28-day cell culture (Vero, MRC, BHK, HeLa, and NIH3T3) | Negative | Negative |
| General in vivo test | Mouse and infant mouse, embryonated egg administration | Negative | Negative |
| Detection test | |||
| Mouse virus | Mouse antibody production | Negative | Negative |
| Rat virus | Rat antibody production | Negative | Negative |
| Hamster virus | Hamster antibody production | Negative | Negative |
| Human virus | qPCR of 14 virus (HIV-1/2, human T-lymphotropic virus type 1/2, hepatitis A virus, hepatitis B virus, hepatitis C virus, HHV-6, HHV-7, HHV-8, cytomegalovirus, Epstein-Barr virus, simian virus 40, and parvovirus B19) | Negative | Negative |
| Bovine/swine virus | FDA 9 CRF method | Negative | Negative |
| Circovirus | qPCR | Negative | Negative |
| Bovine Parvovirus | qPCR | Negative | Negative |
| Swine hepatitis E virus | qPCR | Negative | Negative |
| Torque Teno virus | qPCR | Negative | Negative |
| Mouse endogenous virus | |||
| Reverse transcriptase | F-PERT high sensitivity reverse transcriptase activity detection | Negative | Negative |
| Electron microscope (transmission electron microscope) | Observation of 200 cells | Negative | Negative |
| S + L–focus assay | Negative | Negative | |
| Replication competent retrovirus | Xenogeneic retrovirus detection | Negative | Negative |
| Aves virus | Detection of replication competent retrovirus in the cell qPCR (adenovirus, chicken parvovirus, avian encephalomyelitis, canine adenovirus, and Reovirus) | Negative | Negative |
| Equine virus | Negative | Negative | |
| Insect virus | FDA 9 CFR method qPCR (Flock house virus, Nodamura virus, Boolarra virus, and Pariacoto virus) | Negative | Negative |
| 4. In vitro tumorigenicity | Colony forming after γ-ray irradiation | Compatible | Compatible |
| Item . | Method . | Criterion . | Result . |
|---|---|---|---|
| 1. Sterility test (bacteria and fungus) | Direct culture (JP, USP, and EP compatible) | Negative | Negative |
| 2. Mycoplasma test | Agar and nonagar culture (JP, USP, and EP compatible) | Negative | Negative |
| 3. Virus tests | |||
| General in vitro test | 28-day cell culture (Vero, MRC, BHK, HeLa, and NIH3T3) | Negative | Negative |
| General in vivo test | Mouse and infant mouse, embryonated egg administration | Negative | Negative |
| Detection test | |||
| Mouse virus | Mouse antibody production | Negative | Negative |
| Rat virus | Rat antibody production | Negative | Negative |
| Hamster virus | Hamster antibody production | Negative | Negative |
| Human virus | qPCR of 14 virus (HIV-1/2, human T-lymphotropic virus type 1/2, hepatitis A virus, hepatitis B virus, hepatitis C virus, HHV-6, HHV-7, HHV-8, cytomegalovirus, Epstein-Barr virus, simian virus 40, and parvovirus B19) | Negative | Negative |
| Bovine/swine virus | FDA 9 CRF method | Negative | Negative |
| Circovirus | qPCR | Negative | Negative |
| Bovine Parvovirus | qPCR | Negative | Negative |
| Swine hepatitis E virus | qPCR | Negative | Negative |
| Torque Teno virus | qPCR | Negative | Negative |
| Mouse endogenous virus | |||
| Reverse transcriptase | F-PERT high sensitivity reverse transcriptase activity detection | Negative | Negative |
| Electron microscope (transmission electron microscope) | Observation of 200 cells | Negative | Negative |
| S + L–focus assay | Negative | Negative | |
| Replication competent retrovirus | Xenogeneic retrovirus detection | Negative | Negative |
| Aves virus | Detection of replication competent retrovirus in the cell qPCR (adenovirus, chicken parvovirus, avian encephalomyelitis, canine adenovirus, and Reovirus) | Negative | Negative |
| Equine virus | Negative | Negative | |
| Insect virus | FDA 9 CFR method qPCR (Flock house virus, Nodamura virus, Boolarra virus, and Pariacoto virus) | Negative | Negative |
| 4. In vitro tumorigenicity | Colony forming after γ-ray irradiation | Compatible | Compatible |
JP, Japanese Pharmacopeia; USP, Unites States Pharmacopeia; EP, European Pharmacopeia; CFR, Code of Federal Regulations; FDA, Food and Drug Administration; HHV, human herpesvirus; F-PERT, fluorescent-product enhanced reverse transcriptase.