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Glycosylated and non-glycosylated recombinant human granulocyte colony-stimulating factor (rhG-CSF)—what is the difference?

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Abstract

Two forms of recombinant human G-CSF (rhG-CSF) are available for clinical use: filgrastim is expressed inE coli and non-glycosylated, whereas lenograstim is derived from Chinese hamster ovary (CHO) cells and glycosylated. The function of the sugar chain, accounting for approximately 4% of the molecular weight of lenograstim (and native G-CSF), is not known. Glycosylation of the G-CSF molecule does not prolong its circulation half life. Lenograstim is more active than filgrastim (and research-use deglycosylated G-CSF) on a weight-by-weight basis inin vitro colony-forming and cell line assays. An international potency standard assigns a specific activity of 100 000 IU/μg to filgrastim and 127 760 IU/μg to lenograstim. Correspondingly, two randomised crossover studies in normal subjects, comparingmass equivalent doses of the two rhG-CSFs, have demonstrated a 25–30% higher concentration of blood stem cells (CD34+, CFU-GM) during lenograstim administration. No difference in side effects was observed. Results from a prospective, randomised, non-crossover trial in breast cancer patients suggest thatbioequivalent doses of filgrastim and lenograstim have a similar effect on mobilisation of CD34+ cells and immature CD34+ cell subsets, respectively. Although comparisons outside the setting of stem cell mobilisation are lacking, the clinical relevance of the greater specific activity of lenograstim may thus be limited. The difference in potency between μg identical doses of the two rhG-CSFs makes dosing in biological units (IU) rather than mass units (μg) more appropriate.

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  1. Department of Internal Medicine, University Hospital, S-751 85, Uppsala, Sweden

    Martin Höglund MD

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Correspondence to Martin Höglund MD.

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Höglund, M. Glycosylated and non-glycosylated recombinant human granulocyte colony-stimulating factor (rhG-CSF)—what is the difference?. Med Oncol 15, 229–233 (1998). https://doi.org/10.1007/BF02787205

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