Preparation of Tc-99m-macroaggregated albumin from recombinant human albumin for lung perfusion imaging

Eur J Pharm Biopharm. 2006 Jan;62(1):26-31. doi: 10.1016/j.ejpb.2005.06.005. Epub 2005 Sep 8.


Human serum albumin (HSA) extracted from pooled blood taken from human donors is used in the production of (99m)Tc-labelled macroaggregated albumin (MAA) for lung perfusion imaging. However, concerns for the safety of blood-derived products due to potential contamination by infective agents (e.g. new variant CJD), make alternative production methods necessary. Recombinant DNA technology is a promising method of albumin production avoiding problems associated with human-derived HSA. This paper presents results comparing MAA prepared from recombinant human albumin (rHA, Recombumin) (rMAA) with in-house produced HSA MAA (hMAA) and commercially available MAA (cMAA). (99m)Tc-MAA was prepared using previously published production methods by heating a mixture of albumin and stannous chloride in acetate buffer (pH 5.4) at 70 degrees C for 20 min. Parameters investigated include aggregate size, radiolabelling efficiency, radiochemical and aggregate stability at 4 degrees C and in vitro (in whole human blood) at 37 degrees C and biodistribution studies. Results showed that rMAA could be produced with similar morphology, labelling efficiency and stability to hMAA and cMAA. Our findings confirm that rHA shows significant potential as a direct replacement for HSA in commercially available MAA.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Albumins / chemistry
  • Animals
  • Drug Stability
  • Female
  • Humans
  • Lung / diagnostic imaging*
  • Particle Size
  • Rabbits
  • Radionuclide Imaging
  • Radiopharmaceuticals / chemical synthesis*
  • Radiopharmaceuticals / pharmacokinetics
  • Recombinant Proteins / chemistry
  • Technetium Tc 99m Aggregated Albumin / chemical synthesis*
  • Technetium Tc 99m Aggregated Albumin / pharmacokinetics
  • Tissue Distribution


  • Albumins
  • Radiopharmaceuticals
  • Recombinant Proteins
  • Technetium Tc 99m Aggregated Albumin