Gerben Zijlstra

Global Technology Consultant Intensified & Continuous Biomanufacturing at Sartorius Stedim Biotech

Sartorius has a unique and extensive platform for process intensification, spanning from PD to commercial and from upstream to downstream. In upstream this includes unique services like cell line development of perfusion optimized cell lines, High Cell Density cell banking and including unique High throughput PD tools like ambr 15 Gen2 and ambr 250 HT perfusion cell culture PD, BioPAT®  Process Insights for seamless scaling and BioPAT ViaMass and Spectro for PAT based process monitoring and control of intensified processes. In downstream a new generation of tools for process intensification including Allegro and BioSMB (continuous) chromatography systems, High capacity Protein A membrane adsorbers along with ambr crossflow TFF PD tools are now becoming available.  

The Ambr 250 High Throughput Perfusion System, for example, is a parallel, single-use bioreactor system with a fully automated liquid handling platform, that accelerates the optimisation of intensified cell culture processes, leading to reduced development times and improved processes with reduced cost of goods. Combined with the latest Raman spectroscopy PAT techniques, statistical models can now be developed efficiently and very fast, which allows you to analyse a large number of metabolites using only one sensor at both PD and later-on manufacturing scale. And the more you can measure, the better you can steer your process. It’s high-throughput and high-insight.
Another example is the BioSMB (simulated moving bed) platform, which provides a flexible multicolumn chromatography system that uses much less medium when compared to traditional batch methodologies. This is achieved through a single-use, eight-column system architecture that enables a highly flexible flow configuration. The BioSMB platform is fully scalable from process development to commercial manufacturing. Our single-use downstream solutions, which can be gamma radiated, can remain in place over many days with very limited risk of contamination or interruption of the process, allowing for effective Bioburden control over longer periods in continuous processes. 
What does the future hold?