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Table 3 Process related impurities of formulated BK0023 preparations

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

  1. EU Endotoxin unit, ppm part per million parts, pg picograms.
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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