Scaling-up and production of therapeutic antibodies for preclinical studies.

Monoclonal antibodies are increasingly used for treatment of various diseases, mostly cancer therapy and auto-immune diseases. New chimeric, humanized, or fully-human antibodies specific to novel or already validated targets are being developed in many academic labs as well as in commercial entities. A validation of antibodies in preclinical settings is an important component of the road from discovery to clinic. Preparing sufficient amount of high-quality antibodies for preclinical studies is a challenge in some cases. This article summarizes protocols used in research laboratories, and is based on our own experience in the establishment of stable clones of CHO cells to scaling-up of tissue cultures for production of antibodies in bioreactors.