From: Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing
Parameter | Method | Acceptance Criteria | WCB-HE-01 | WCB-HE-02 | WCB-HE-03 |
---|---|---|---|---|---|
Morphology | Visual Inspection | Adherent cells with thin extensions | Adherent cells with thin extensions | Adherent cells with thin extensions | Adherent cells with thin extensions |
Identification | PCR | Presence of: D5S818: 8/9 D13S317: 12/14 D7S820: 11 D16S539: 9/13 vWA: 16/18/19 TH01: 7/9/3 Amelogenin: X TPOX:11 CSF1PO: 11/12 | 8/9 12/14 11 9/13 16/18/19 7/9.3 X 11 11/12 | 8/9 12/14 11 9/13 16/18/19 7/9.3 X 11 11/12 | 8/9 12/14 11 9/13 16/18/19 7/9.3 X 11 11/12 |
Sterility | Eu. Ph 2.6.1 | Sterile | Sterile | Sterile | Sterile |
Mycoplasma | Eu. Ph 2.6.7 | Absent | Absent | Absent | Absent |
Karyotype | G-Band Staining | Informative | Complex | Complex | Complex |
Adventitious viruses | Internal method | Absence of cytopathic effect | Absence | Absence | Absence |
Viability after thawing | Trypan Blue Assay | ≥ 50.0% | 97% | 94.4% | 96.4% |