Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products

Revista Brasileira de Hematologia e Hemoterapia

Cristiane F. Codevilla¹  Thiago Barth¹  Liberato Brum Júnior¹  Marcio Fronza¹  Sérgio L. Dalmora¹ 

[1] ,Universidade Federal de Santa Maria Centro de Ciências da Saúde Departamento de Farmácia IndustrialSanta Maria RS ,Brazil

关键词: Filgrastim;    recombinant human granulocyte colony-stimulating factor;    neutropenia;    bioassay;    Filgrastima;    fator estimulador da colônia de granulócitos humanos recombinante;    neutropenia;    bioensaio;   

DOI  :  10.1590/S1516-84842004000200007

来源: SciELO

【 摘 要 】

The identification of rhG-CSF was carried out in pharmaceutical preparations by non-reducing polyacrylamide gel electrophoresis and western blotting with specific antibodies, showing a single band in the 19 kDa region. The potency was assessed by the neutropenia mouse bioassay giving values between 88.4 and 122.4% of the stated potency. The precision index expressed by weight was between 141 and 432 for the independent assays. Batch-to-batch, the samples met the requirements for the safety test and bacterial endotoxins test. The biological and immunological results showed the quality of the products in clinical use and the specifications established contribute to assuring the safety and efficacy of biological medicines.

【 授权许可】

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