Process intensification in biologics manufacturing

Abstract Over the last decade, the term process intensification (PI) has been applied almost exclusively to large scale chemical processes, but hardly to aspects of biopharmaceutical manufacturing, and not at all to relatively small scale, but high value generating pharmaceutical productions. Personalized and stratified medicine approaches for innovative therapies are changing that as well as economic limitations for health care systems in ageing society. Recent developments have resulted in new concepts for biologics manufacturing. The chemical engineering tool box for the adoption of process intensification methods to biologics is ready for industrial transfer; e.g. process modelling and comprehension, miniaturization/ scaled-down equipment for rapid process development, advanced process control, innovative analytics, mass transfer enhancement and process integration. Nevertheless, methods and equipment of process intensification, developed for chemical engineering applications, which are not as strictly regulated as in the case of biologics manufacturing, cannot simply be transferred to biotherapeutical applications. They require specific adjustment to the technological and regulatory requirements, for example any process intensification step within process development has to be finalized before producing first supplies for clinical trials. This generates quite a challenge with regard to technical readiness level and organization of companies in process development and implementation.