Established bioprocesses for producing antibodies as a basis for future planning.

In the early years of monoclonal antibody production for human therapy and diagnosis the methods used were arrived at by individual organisations. However, there is now an accumulating body of information on antibodies and fragments that have been produced by processes approved for human use. This information is becoming available at a time when the number of potential antibody-based medicines is growing sharply. The review addresses the reported production routes, their scale and the titres achieved. It identifies the performances of fed-batch and perfusion culture versus batch culture, and compares processes for the production of antibodies for diagnosis and for antibody fragments. The analysis defines the likely routes of future production in a sector where demanding regulations constrain new technology. It also indicates what levels of performance new approaches will need to meet to be competitive.