Freeze-dried formulation for direct 99mTc-labeling ior-egf/r3 MAb: additives, biodistribution, and stability

• Published in: Nuclear medicine and biology Vol. 26; no. 6; pp. 717 - 723
• Main Authors: Morales, Alejo A.Morales, Núñez-Gandolff, Gilda, Pérez, Niuvis Pérez, Véliz, Belkis Chico, Caballero-Torres, Idania, Ducongé, Jorge, Fernández, Eduardo, Crespo, Francisco Zayas, Veloso, Ana, Iznaga-Escobar, Normando
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier Inc 01-08-1999; Elsevier
• Subjects: Animals; Antibodies, Monoclonal - chemistry; Antibodies, Monoclonal - pharmacokinetics; Biodistribution; Biological and medical sciences; Drug Stability; Female; Freeze Drying; Freeze-dried; Glucose; Humans; Investigative techniques, diagnostic techniques (general aspects); Medical sciences; Miscellaneous. Technology; Monoclonal antibodies; Radiolabeling; Radionuclide investigations; Radiopharmaceuticals - chemistry; Radiopharmaceuticals - pharmacokinetics; Rats; Rats, Wistar; Technetium - pharmacokinetics; Technetium-99m; Tissue Distribution; Monoclonal antibodies; Radiolabeling; Biodistribution; Freeze-dried; Technetium-99m; Radionuclide study; Freeze dried product; Stability; Rat; Rodentia; Technetium; Monoclonal antibody; Scintigraphy; Vertebrata; Mammalia; Epidermal growth factor; Efficiency; Animal; Preparation; Distribution; Medical imagery; Pharmacokinetics; Immune system
• ISSN: 0969-8051; 1872-9614
• DOI: 10.1016/S0969-8051(99)00038-4

Monoclonal antibodies (MAbs) have been useful for immunoscintigraphic applications in clinical diagnosis since they were introduced in nuclear medicine practice. The MAb ior egf/r3 developed at the Center of Molecular Immunology (Havana, Cuba) is a murine antibody that recognizes the human epidermal growth factor receptor (EGF-R) and has been used widely in the radioimmunodiagnosis of tumors of epithelial origin. Based on the direct Schwarz method, the present report describes the preparation of a freeze-dried formulation for radiolabeling the MAb ior egf/r3 with
99mTc for immunoscintigraphic applications. Radiolabeling efficiency, effects on immunoreactivity, biodistribution, pharmacokinetic, and stability of the formulation are reported. The study demonstrated that the freeze-dried formulation can be labeled with
99mTc at high yield. The resulting
99mTc-labeled ior egf/r3 MAb can be used to visualize
in vivo human tumors of epithelial origin by immunoscintigraphy studies. The kit does not need any other addition or purification at the time of tagging other than the requisite amount of pertechnetate (40–50 mCi). Because the contents of the kit are lyophilized, no special storage or transportation is required.