The preparation of radiolabeled monoclonal antibodies for human use

Modalities like antibody based radioimmunotherapy and radioimmunoscintigraphy require the development and the use of radiolabeled monoclonal antibodies. For this, a radiolabeling procedure has to be designed for the preparation of radiolabeled monoclonal antibodies. As the radioconjugate is intended for human use, it has to possess characteristics like preservation of the immunoreactivity, high (radio)chemical purity, and high specific activity. Therefore, the labeling procedure has to meet several requirements. To guarantee a reproducible quality of the radiolabeled product, the whole labeling procedure has to be performed according to the rules of Good Manufacturing Practice (GMP). In addition, to warrant the safety of involved personnel, safety measurements have to be taking into account, to minimize radiance exposure. This review describes selected methods for the preparation of radiolabeled monoclonal antibodies for human use emphasizing pharmaceutical issues such as manufacturing and quality control.