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Table 1 Biosafety tests carried out on the NclFed1A master cell bank

From: Production and validation of a good manufacturing practice grade human fibroblast line for supporting human embryonic stem cell derivation and culture

Test

Reference

Test result

Sterility test and qualification of test article by direct inoculation method

[38]

Negative

Test for Mycoplasma spp.(Including mycoplasmastasis assay)

[38]

Negative

Retroviruses: detection of reverse transcriptase (F-Pert assay)

[39–47]

Negative

Detection of human viral pathogens (HIV 1 and 2 provirus, HTLV 1 and

2 provirus, HAV, HBV, HCV, HHV-6, HHV-7, HHV-8, hCMV, EBV, SV40 and B19) by real-time polymerase chain reaction (PCR).

[48]

Negative

Detection of bovine viruses with in vitro adventitious assay according to 9CFR Guidelines

[43, 45, 47, 49–52]

Negative

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Stem Cell Research & Therapy

ISSN: 1757-6512