AI Article Synopsis
- KRN321 is a modified form of erythropoietin used in studies to understand its pharmacokinetics.
- A validation study used an ELISA assay to measure KRN321 levels in rat serum, achieving accurate quantification between 100 pg/mL and 4,000 pg/mL.
- The in vitro bioassay method correlated well with the ELISA results, confirming that the levels measured maintain biological activity.
Article Abstract
KRN321, darbepoetin alfa, is a hyperglycosylated analog of recombinant human erythropoietin (rHuEPO, epoetin alfa). We carried out the validation study by using a commercially available ELISA assay kit to establish the ELISA quantitation method for KRN321 in rat serum for the implementation of the pharmacokinetic studies with a lower limit of quantitation at 100 pg/mL and quantitation range from 100 to 4,000 pg/mL. We also established the in vitro bioassay method as an index of biological activity using UT-7/Epo, derived from a human leukemia cell line with a lower limit of quantitation, at 10 ng/mL. Furthermore, good correlation was observed between the two methods; it indicated that KRN321 concentration determined by the ELISA maintained biological activity.
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