Comparative evaluation of the pharmacokinetics of three monoclonal Factor VIII concentrates

M. Morfini, P. M. Mannucci, G. Longo, S. Cinotti, A. Messori

Research output: Contribution to journalArticlepeer-review

Abstract

Hemofil M, Monoclate HT, and Monoclate P are high-purity Factor VIII concentrates, obtained from plasma by immunoaffinity chromatography with monoclonal antibodies specific for Factor VIII (Hemofil M) or von Willebrand Factor (Monoclate HT and Monoclate P). The concentrates are subjected to virucidal treatments: a solvent/detergent method (TNBP/Na-cholate) for Hemofil M, heating in the lyophilized state and in solution (pasteurization) for Monoclate HT and Monoclate P, respectively. Since these differences in the manufacturing process might result in different in vivo characteristics of the concentrates, we compared their in vivo behavior in a cross-over, single-dose, pharmacokinetic study performed in 10 non-bleeding patients with severe hemophilia A. The experimental conditions (Factor VIII dose, number and timing of blood sampling, Factor VIII assay methods, calculation of pharmacokinetic parameters) were identical for the three products. The results showed that the clearance, the mean residence time, and the volume of distribution did not differ among the three products.

Original languageEnglish
Pages (from-to)285-290
Number of pages6
JournalThrombosis Research
Volume61
Issue number3
DOIs
Publication statusPublished - Feb 1 1991

Keywords

  • Monoclonal Factor VIII concentrates
  • Pharmacokinetics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Hematology

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