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Table 1 Environmental parameters of MCB process validation. Table summarizing the environmental parameters obtained during the production of MCB batches. Airborne particles concentration in the sterile cabinet (Grade A) was measured at each step of the procedure. Particles equal or greater than 0.5 µm met defined acceptance criteria. Particles equal or greater than 5 µm met defined acceptance criteria. Glove prints of personnel operating in the cabinet (Grade A) were sampled at each step of the procedure. No microorganisms were detected in agreement with the acceptance criteria. The presence of airborne microorganisms in the cabinet (Grade A) was monitored at each step of the procedure by using settle plates. No microorganisms were detected on the plates, meeting defined acceptance criteria

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

Environmental Parameters

Culture Day

Batch code:

MCB-HE-01

Batch code:

MCB-HE-02

Batch code:

MCB-HE-03

≥ 0.5 µm particles/m3

HEK293T Thawing

Pass

Pass

Pass

1st passage

Pass

Pass

Pass

2nd passage

Pass

Pass

Pass

MCB Generation

Pass

Pass

Pass

≥ 5 µm particles/m3

HEK293T Thawing

Pass

Pass

Pass

1st passage

Pass

Pass

Pass

2nd passage

Pass

Pass

Pass

MCB generation

Pass

Pass

Pass

Glove Print CFU

HEK293T Thawing

0

0

0

1st passage

0

0

0

2nd passage

0

0

0

MCB generation

0

0

0

Settle plates CFU

HEK293T Thawing

0

0

0

1st passage

0

0

0

2nd passage

0

0

0

MCB generation

0

0

0