A sandwich ELISA for assessment of pharmacokinetics of HSA-(BNP)2 fusion protein in mouse plasma

J Pharm Biomed Anal. 2010 Feb 5;51(3):658-63. doi: 10.1016/j.jpba.2009.09.010. Epub 2009 Sep 12.

Abstract

Brain natriuretic peptide (BNP) is a circulating hormone of cardiac origin that plays an important role in the regulation of intravascular blood volume and vascular tone. HSA-(BNP)(2), derived from the joining of human BNP to the C-terminus of human serum albumin (HSA), has been developed to prolong the BNP pharmacodynamic action. For the analysis of pharmacokinetics of the new drug, a novel sandwich enzyme-linked immunosorbent assay (ELISA) was established and validated to quantify HSA-(BNP)(2) fusion protein in mouse plasma. The ELISA method was calibrated with 1:10 and 1:100 dilutions of blank mouse plasma spiked with HSA-(BNP)(2) standard and validated with respect to parallelism, precision (intra- and inter-assay variation), accuracy (recovery), specificity and stability. The practical working range was estimated to be 31.2-2000ng/ml with the limit of detection was 7.8ng/ml. Recoveries ranged from 80.5 to 108.4%, while the intra- and inter-assay precisions were <2.73% and <4.32%, respectively. The terminal half-life of HSA-(BNP)(2) was 2.14h, which had extended more than 40 times compared to 3.1min half-life of BNP monomer in mouse.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Enzyme-Linked Immunosorbent Assay / methods
  • Enzyme-Linked Immunosorbent Assay / standards
  • Female
  • Humans
  • Male
  • Mice
  • Natriuretic Peptide, Brain / blood*
  • Natriuretic Peptide, Brain / pharmacokinetics*
  • Natriuretic Peptide, Brain / standards
  • Protein Binding / physiology
  • Random Allocation
  • Recombinant Fusion Proteins / blood*
  • Recombinant Fusion Proteins / pharmacokinetics*
  • Recombinant Fusion Proteins / standards
  • Serum Albumin / analysis
  • Serum Albumin / pharmacokinetics*
  • Serum Albumin / standards

Substances

  • Recombinant Fusion Proteins
  • Serum Albumin
  • Natriuretic Peptide, Brain