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Table 4 WCB specifications. Table summarizing results obtained during the analyses of WCB batches. All WCB batches met the acceptance criteria

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%