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Table 2 MCB specifications. Table summarizing results collected during MCB batch analyses. All MCB batches met defined acceptance criteria

From: Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing

Parameter

Method

Acceptance Criteria

MCB-HE-01

MCB-HE-02

MCB-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%

91.9%

96.9%

93.8%