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We accompany our customers for the definition of their bioasfety testing strategy for gene therapy production, based on human or insect cells.
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MCB |
WCB |
CAL |
UBH |
PBH |
FPa |
| Mycoplasma assay |
x |
x |
x |
x |
|
x |
| Sterility assay |
x |
x |
x |
x |
x |
x |
| In vitro assay for detection of adventitious virus |
x |
x |
x |
x |
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| In vitro assay for detection of bovine and porcine virus |
x |
|
x |
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| Identity (DNA finger printing, caryotyp, species identity) |
x |
x |
x |
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| Detection of retrovirus (Q-PERT) |
x |
|
x |
x |
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| Detection of viral particles by electron microscopy examination |
x |
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x |
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| In vivo assay for detection of adventitious virus |
x |
x |
x |
x |
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| Detection of (specific) adventitious virus (PCR) |
x |
|
x |
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| Tumorigenicity |
x |
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| Genetic stability |
x |
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x |
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| Bacterial endotoxins |
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|
x |
x |
| Residual Host Cell DNA |
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|
x |
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| Residual Host Cell Protein |
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|
x |
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| Detection and measurement of A Protein |
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|
x |
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| Abnormal toxicity test |
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x |
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MCB : Master Cells Bank ; WCB : Working Cells Bank ; CAL : Cells At Limit ; UBH : Unprocessed Bulk Harvests ; PBH : Processed Bulk Harvests ; FP : Final Product
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Services 
