Integrated Continuous Downstream Processes for Next-generation of Biologics

Purpose and goal

The introduction of a new production paradigm in the biopharmaceutical industry requires methods and tools for process development at all stages in the development of new drugs. This project has developed new methodology and tools for designing and automating integrated continuous downstream processes for increased flexibility and controllability in development in both preclinical and clinical studies.

Expected results and effects

The project has resulted in three industrial case studies; 1) an integrated continuous downstream process connected to a continuous perfusion reactor at Novo Nordisk, long-term production, 2) an integrated downstream process from Sobi, 3) an integrated downstream process with a protein modification reactor also scaled up for industrial needs at Novo Nordisk. The project has also delivered a number of results; new version of orbit, an optimization tool, five scientific publications, four technical reports and nine MSc theses.

Planned approach and implementation

The project was built on four work packages. Work packages 1 and 2 have shown how integration of entire downstream processes including reaction steps can be done both in the physical process and in the automation system. Work Package 3 has developed a new version of the research software orbit for automation with better internal structure, increased functionality, more ways of communication. Work package 4 has developed an optimization tool that supports the developed design methodology in the project.