Margit Holzer, PhD, owner of Ulysse Consult, is chairing a session on the future of bioprocessing at this year’s Bioprocessing Summit Europe. She talks to GEN about new molecules, technologies, and products.
GEN: What are the biggest factors driving the future of bioprocessing?
Holzer: We need to think about the new biological products we must work with. Products, such as CAR-T, plasmids, viral vectors and RNA or DNA vaccines, are larger and much more complex. We need adapted and different production systems to make these products, increase their productivity, and speed up development.
Furthermore, I see productivity improvements in the production of existing products, such as monoclonal antibodies and recombinant insulin.
GEN: How do you see bioprocess changing in the future?
Holzer: Production systems will become smaller. The production environment will move to be more flexible and compartmentalized. R&D workflows might become more integrated, with online data exploitation and process simulations available to accelerate development. Manufacturing execution systems may end up combined with bioprocessing tools to connect, control, and automate standard unit operations.
Most likely, the role of suppliers will become even more important with the development of new disposable technologies, standardized product lines, and automated ready-to-use systems.
GEN: What novel technologies should the industry look at?
Holzer: For new biological products, we may require different expression systems derived from CHO or HEK cell lines, or E. coli expression systems for plasmids. New cell types often have different needs for mixing, gassing, or feeding, and this is especially important during scaleup.
In upstream bioprocessing, we may have to work with new production systems, such as continuous perfusion methods for unstable products or those with high quality requirements. In the downstream area, we may need to adjust filters, membranes, and chromatography materials to deal with larger molecules. Optimizing pore sizes of chromatography media to allow product penetration is one example.
The industry is already focused on process intensification and analyses of processes. We can extract online monitoring data from ongoing production processes, analyze them, and use them for process optimization. Such systems might use data from standard sensors, such as pH or conductivity, or based on new technology such as Raman spectroscopy. Reliable tools allowing for rapid analyses, trend detection, process optimization and characterization also contribute to the future of our industry.
GEN: How quickly will this happen?
Holzer: We need to be patient, as there are a lot of things to do, but I’m also excited, having worked in the bioprocessing industry for the last 30 years.