Challenges in biotechnology production—generic processes and process optimization for monoclonal antibodies

In manufacturing of biological drugs, product quality is defined by the process (e.g. equipment, sequence of unit operations, operation parameters) because no complete analysis of these complex molecules is possible. Therefore, the process is unavoidably fixed after the first clinical lot production in a pilot plant. There is no further process optimization option parallel to production, which, in the case of small molecule productions, allows further process optimization. Process development times will not increase in future due to increasing pressure on time to market. In addition to that, no change in paradigm seems possible, as complete analysis of complex biomolecules comparable to small synthetic drugs is not seen in near future. As a consequences the challenge is to establish generic processes for different drug classes and to find consistent process development methods, which allow a reliable prediction of large-scale production. Generic in this sense is not understood as a fixed sequence of unit operations with a certain set of generic process parameters. Here, generic means that a typical arrangement of unit operations is set up in an efficient sequence to fulfil the separation task.