Pharmaceutical quality control of radiolabeled monoclonal antibodies and their fragments.

Abstract

Monoclonal antibodies are immunochemical reagents whose functional integrity is critical to their clinical applications. Quality control through each stage from antibody production through purification and radiolabeling is necessary if radiopharmaceuticals with reproducible in vivo characteristics are to be achieved. This article describes some of the quality control methods that can be used during developmental and clinical stages of evolution of these radiopharmaceuticals.