Biological potency evaluation and characterization of rhG-CSF in pharmaceutical products
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.
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| Main Authors: | , , , , |
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| Format: | Digital revista |
| Language: | English |
| Published: |
Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular
2004
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| Online Access: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842004000200007 |
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