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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) [3947] 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, 4952] Negative