Therapeutic antibody

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Therapeutic antibodies

Therapeutic antibody

We accompany our customers for the definition of their bioasfety testing strategy for therapeutic antibody production, based on human, murine, avian or CHO cells.

For more information, please click on the list below.

	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, karyology, species identity)	x	x	x
Detection of retrovirus (Q-PERT)	x		x	x*
Detection of viral particles by electron microscopy examination	x		x*	x*
In vivo assay for detection of adventitious virus	x	x*	x	x*
Detection of (specific) adventitious virus (PCR)	x		x
Tumorigenicity	x*		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.
* depends of the cell line used.

Click here to know more about our viral sefety testing on avian cells

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