title: Stability of radioiodinated monoclonal antibodies: in vitro storage and plasma analysis.
abstract: The in vitro stability and immunointegrity of four radioiodinated monoclonal antibodies was evaluated in various storage conditions and also in plasma samples. The monoclonal antibodies studied included T101, B72.3, Lym1, and 16.88. Stabilities of typical monoclonal antibody therapy solutions, with radioactivities ranging from 2220 to 3700 MBq (60-100 mCi) were assessed using conventional instant thin layer chromatography and size exclusion high performance liquid chromatography. Radioimmunoreactivity was assessed using a live cell attenuated cell, or mucin-linked bead assay. Results of the study demonstrated that therapy solutions were stable to degradation, if properly stored in 5 or 10% human serum albumin at 4 degrees C for the duration of the study (5 days). Minor losses in immunoreactivity were also measured in stabilized therapy solutions. When incubated in plasma samples, radioiodinated monoclonal antibodies generally remained stable for the duration of the study (3 days). However, significant decreases in immunoreactivity were measured for specific radioiodinated monoclonal antibody preparations.
authors.affiliation: Department of Radiology, Northwestern University Medical Center, Chicago, IL 60611.
authors.forename: A M
authors.initials: AM
authors.lastname: Zimmer
authors.forename: J M
authors.initials: JM
authors.lastname: Kazikiewicz
authors.forename: D I
authors.initials: DI
authors.lastname: Webber
authors.forename: B A
authors.initials: BA
authors.lastname: Patel
authors.forename: R
authors.initials: R
authors.lastname: Goldman-Leikin
authors.forename: J A
authors.initials: JA
authors.lastname: Radosevich
authors.forename: W G
authors.initials: WG
authors.lastname: Spies
authors.forename: S M
authors.initials: SM
authors.lastname: Spies
authors.forename: S T
authors.initials: ST
authors.lastname: Rosen
mesh_terms: D000911:Antibodies, Monoclonal / Q000276:immunology / Q000627:therapeutic use*; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D066298:In Vitro Techniques; D007457:Iodine Radioisotopes / Q000627:therapeutic use; D010949:Plasma; D012709:Serum Albumin
chemical_list: D000911:Antibodies, Monoclonal; D007457:Iodine Radioisotopes; D012709:Serum Albumin