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Table 1 Analytical comparison between BK0023 and Neupogen ®

From: Preclinical and clinical phase I studies of a new recombinant Filgrastim (BK0023) in comparison with Neupogen®

Parameter

Analysis

Results and notes

Structural and conformational characterisation

First 15 N-terminal residues by automatic Edman degradation

Results agree with the expected sequence

Reducing and non-reducing Glu-C proteolysis and RP-HPLC/MS mapping

Primary structure and disulfide bridge positions according to the expected sequence

MALDI-TOF-MS

According to the calculated value

SDS-PAGE

Migration profile comparable to Neupogen®

SE-HPLC

Elution profile comparable to Neupogen®

Identity

Western blotting

Binding to specific antibody as Neupogen®

RP-HPLC

Elution profile comparable to Neupogen®