From: Preclinical and clinical phase I studies of a new recombinant Filgrastim (BK0023) in comparison with Neupogen®
Impurity
Method
Result
Bacterial endotoxins
LAL test
< 5 EU/mg
Host proteins (ECP)
Immunoenzymatic assay
< 20 ppm
Host/vector DNA
Hybridation to degenerated probe
< 100 pg/mg