| 摘要 |
A process for the purification and/or isolation of biologically active granulocyte colony stimulating factor (G-CSF) is described. It involves the following steps: i. providing a mixture which comprises a biologically active form of G-CSF in the presence of an impurity, and ii. subjecting the mixture to immobilised metal affinity chromatography (IMAC). The process can be advantageously performed under native conditions, resulting in the biologically active G-CSF with a purity of greater than 95%. Additional chromatographic steps, cationic exchange chromatography and gel filtration, is described to result in the production of higher yields of G-CSF with a purity of greater than 99%. The process enables the separation of correctly folded biologically active monomeric molecules of G-CSF from the incorrectly folded, oligomeric, polmeric and biologically inactive monomeric forms of G-CSF. The use of the biologically active G-CSF obtained by the process described is disclosed to be for the production of medicaments for indications selected from the group consisting of neutropenia-related clinical sequelae, as well as neutropenic and non-neutropenic infections.
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