Ellison David, Kaufman Jens, Mather Stephen J
Centre for Molecular Oncology and Imaging, Institute of Cancer, Barts and The London School of Medicine, John Vane Science Centre, Charterhouse Square, London, UK.
Nucl Med Commun. 2010 Feb;31(2):173-7. doi: 10.1097/MNM.0b013e3283348771.
Automation of radiopharmaceutical preparation represents a way of reducing radiation doses to operators and providing good manufacturing practice-compliant manufacture of radiopharmaceuticals. Although widely adopted for PET radiochemical synthesis, such methods have not widely been used for the preparation of therapeutic radiopharmaceuticals. Here we describe an evaluation of an automated system for the preparation of radiolabelled antibodies. A labelling method based on the Modular Lab system was developed and applied to the radiolabelling of the monoclonal antibody conjugate, YAML568-CHX'A-DTPA, with indium-111. Antibodies were labelled using both manual and automated means and analysed by high-performance liquid chromatography and thin-layer chromatography methods. Radiochemical purities achieved using automation (mean 98%) were slightly lower than those achieved manually (mean 99%); however, the radiochemical purity obtained was reproducible and well within the set specification of greater than 95%. The Modular Lab system can be used to automate the radiolabelling of monoclonal antibody-chelate conjugates with metallic isotopes such as indium for the potential application for therapeutic radionuclide therapy.
放射性药物制备的自动化是一种减少操作人员辐射剂量并确保放射性药物生产符合药品生产质量管理规范的方法。尽管这种方法已广泛应用于正电子发射断层显像（PET）放射性化学合成，但尚未广泛用于治疗性放射性药物的制备。在此，我们描述了一种用于制备放射性标记抗体的自动化系统的评估。开发了一种基于模块化实验室系统的标记方法，并将其应用于用铟-111对单克隆抗体偶联物YAML568-CHX'A-DTPA进行放射性标记。抗体分别采用手动和自动化方式进行标记，并通过高效液相色谱法和薄层色谱法进行分析。使用自动化方法获得的放射化学纯度（平均98%）略低于手动方法（平均99%）；然而，所获得的放射化学纯度具有可重复性，且完全符合设定的大于95%的规格要求。模块化实验室系统可用于自动化单克隆抗体-螯合物偶联物与金属同位素（如铟）的放射性标记，以用于治疗性放射性核素治疗的潜在应用。
