Bioactivity of recombinant human granulocyte colony-stimulating factor

Abstract

Objective: To evaluate the bioactivity of recombinant human granulocyte colony-stimulating factor (rhG-CSF) and application of the relevant test methods in recent years. Methods: The bioactivities of 41 batches of rhG-CSF samples from different origins were determined by mNFS-60 cells/MTT method, and the results were compared with those determined by National Institutes for Food and Drug Control (NIFDC), based on which the reliability of determination result by NIFDC was evaluated. Results: The rhG-CSF bioactivities of 37 batches of domestic products met the requirements in Chinese Pharmacopoeia (Volume III, 2010 edition), while those of four batches of imported products met the relevant quality standards (JS20070016). No significant differences were observed between the determination results by the manufacturers and those by NIFDC (P > 0.05). Conclusion: The bioactivities of rhG-CSF going into market in recent years met the requirements in Chinese Phar-macopoeia (Volume III, 2010 edition), of which the test method was applied normally in the whole country.