Development of Pegfilgrastim Potency Testing by Cell Proliferation

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Sompong Sapsutthipas
Jiradej Patchim
Saiwarul Jadoonkittinan
Supaporn Phumiamorn

Abstract

     Pegfilgrastim is a growth factor that stimulates the growth of white blood cells. At present, there is no standard method for determining the potency of this drug in any international pharmacopoeia Therefore, a cell proliferation assay was developed by stimulating the adapted M-NSF-60 with diluted drugs at a suitable concentration. The increasing number of cells was measured by using luminescence substrate. The results were analyzed using a parallel line analysis program to determine the drug potency. After the method had been validated, the results showed that pegfilgrastim could stimulate the adapted M-NSF-60 multiplication. For the accuracy, the %recovery within the acceptance criteria from 80% to 125%. The precision of the method, the %GCV of repeatability and intermediate precision were 9.70 and 9.65, respectively, with a linearity and appropriate range between 50–200%. The linearity and range exhibited the r2 value of 0.997. The robustness of the method was tested by modifying the passage numbers of cells and the incubation time., the %GCV was <25% and there was no significant difference at the 95% confidence level. All data show that the newly developed method is suitable for use as a method for determining the potency of pegfilgrastim 3 brands used in this study. For other brands of drugs must verify the method before applying.

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