Strategies for the process development of monoclonal antibodies for therapeutic use

The launch on the market of an increasing number of antibody-based drugs had, as consequence, the parallel development of recipient cell lines, serum free media and bioreactors for production of big quantities of these molecules. Most of the destiny of a biopharmaceutical drug is played during the process development, a step that appears in all biotech projects but very often is not properly carried out with the hurry to go to production. This loss of accuracy at early stages of the development can cause problems in reliability of lots during manufacturing with potential risks of stopping/delaying the project in advanced phases of development. We describe here a strategy for the process development of monoclonal antibodies for clinical studies.