Process intensification (PI) can speed up both R&D and large-scale production, according to Sartorius, who have a range of PI products on the market.
“These turbulent times call for a faster path from lead to product to scale-up”, says Gerben Zijlstra, Technology Consultant Manager Continuous BioManufacturing at Sartorius Stedim Biotech, “and for cheaper and more efficient production once a product is on the market. PI is key in both areas.”
One of Sartorius’ main PI vehicles is its Ambr® product line. Its flagship is Ambr® 250 High Throughput Perfusion, a parallel bioreactor system for rapid development of scalable perfusion processes. It uses 250 mL single-use bioreactors and a fully automated liquid handling platform. “Ambr is a great tool to quickly develop robust processes and accelerate complicated perfusion processes”, says Zijlstra. “The result is multiple-fold higher yields, allowing much smaller, single-use manufacturing facilities and reduced cost of goods.”
Other major advances have been made in downstream processing. In 2020, Sartorius acquired the fully single-use BioSMB (simulated moving bed) platform for continuous chromatography. It provides a flexible multicolumn chromatography system with up to five times higher productivity, and much less resin use, when compared to traditional batch methodologies. This is achieved with an eight-column system architecture that enables a highly flexible flow configuration. “BioSMB combines continuous capture, concentration and purification in a single system”, explains Zijlstra.
“We can now use statistics for advanced process tuning”
The BioSMB platform is fully scalable from process development to commercial manufacturing. There are two commercial scale systems available targeted for perfusion and batch processes. Zijlstra: “The combination of upstream perfusion and this new level of continuous downstream processing leads to an entirely new generation of production platforms.”
Importantly, Sartorius is also introducing new developments in process analytical technology. “We can now use statistics for advanced process tuning”, says Zijlstra. “The latest Raman spectroscopy techniques play an important role in this. It can be integrated in our Ambr systems. A statistical model allows you to analyse a large number of metabolites using only one sensor. The more you can measure, the better you can steer your process. It’s high-throughput and high-insight.”
Sartorius combines its products with a high level of customization. “Our clients don’t have to reinvent the wheel”, says Zijlstra. “We support them from cell line design and medium optimization to the infrastructure for high-density perfusion and scale-up. Plus, of course, harmonization and standardization of processes. The entire package helps them to significantly reduce development time and cost.”