Gene therapy products

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Gene therapy products

We accompany our customers for the definition of their bioasfety testing strategy for gene therapy production, based on human or insect cells.

	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
In vitro assay for detection of bovine and porcine virus	x		x
Identity (DNA finger printing, caryotyp, species identity)	x	x	x
Detection of retrovirus (Q-PERT)	x		x	x
Detection of viral particles by electron microscopy examination	x			x
In vivo assay for detection of adventitious virus	x	x	x	x
Detection of (specific) adventitious virus (qPCR)	x		x
Tumorigenicity	x
Genetic stability	x		x
Bacterial endotoxins					x	x
Residual Host Cell DNA					x
Residual Host Cell Protein					x
Detection and measurement of A Protein					x
Abnormal toxicity test						x

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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