Establishment And Validation Of New Testing Methods For Recombinant Human Granulocyte- Colony Stimulating Factor (rhG-CSF)

Object:Recombinant Human Granulocyte-Colony stimulating factor (rhG-CSF) has been included in the 3rd section of Chinese Pharmacopoeia 2010 edition, and has systemic specification and method requirements for bulk, intermediate, drug product, but needed to be improved compared with those in foreign Pharmacopoeias. Referring to the detailed specifications in USP and EP, new testing methods have been established and validated. The results provide a basis for the future quality improvement in China.Methods:we have established new testing methods for Recombinant Human Granulocyte-Colony stimulating factor (rhG-CSF), including SDS-PAGE, IEF, RP-HPLC, SEC-HPLC, in vitro potency assay (NFS-60,MTS), endotoxin assay by dynamic turbidity.Results:New testing methods of purity, in vitro potency, endotoxin for Recombinant Human Granulocyte-Colony stimulating factor (rhG-CSF) have been established and validated.Conclusions:we have used new testing methods to inspect Recombinant Human Granulocyte-Colony stimulating factor (rhG-CSF) produced in Hangzhou Jiuyuan Gene Engineering co. ltd in accordance with EP and USP quality specifications, and the results comply with EP and USP. Our results provide a basis for the future quality improvement of Recombinant Human Granulocyte-Colony stimulating factor (rhG-CSF) in China.