Development of A Method for Determination of Biologic Activity of Recombinant Human Ciliary Neurotrophic Factor

Objective To develop a method for determination of biologic activity and for effective quality control during preparation and production of recombinant human ciliary neurotrophic factor(rhCNTF).Methods Qualitative and semi-quantitative determinations of rhCNTF were carried out by cultures of ciliary ganalia cells and dorsal root ganglia of chicken embryo respectively.The activity of rhCNTF was determined by TF-1.CN5a.1 cell proliferation method.The biologic activity of rhCNTF in obesity was determined by bodyweight decrease test in normal mice.The four methods were investigated for experimental conditions and evaluated for advantages and shortcomings.Results All the four methods were suitable for the determination of biologic activity of rhCNTF.However,the TF-1.CN5a.1 cell proliferation method combined with bodyweight decrease test in normal mice was more effective.Conclusion The quality of rhCNTF may be controlled by TF-1.CN5a.1 cell proliferation method combined with bodyweight decrease test in normal mice.