Development of ‘ambr 250 perfusion’ – A Novel Automated Single-Use Perfusion Mini-Bioreactor
Speaker: Kevin McHugh -- Sartorius Stedim North America Inc.
In recent years a strong trend towards continuous processing has gathered momentum, driven by the promise of process intensification, reduced cost of goods, and more consistent and better controlled product quality. Benchtop bioreactors provide a route to developing this new wave of intensified/continuous cell culture processes. However this approach is manually intensive, relatively low throughput and cost-intensive to operate. The ambr bioreactor systems have been widely implemented as a high-throughput approach to screening and process development of fed-batch cultures. The ambr product line is expanding to include ambr 250 perfusion, which enables up to 24 single-use perfusion cultures to be carried out simultaneously under fully automated control. The ambr 250p reduces the complexity and expense associated with medium to large scale perfusion culture systems and makes optimization experiments involving DOE approaches more straightforward to complete. This workshop will highlight the key features of this novel system and showcase case studies that show system robustness and capability of reaching culture densities greater than 100 million cells/mL. Lastly, data will be presented showing the capability of this system to be used for both traditional perfusion processes as well as intensified fed-batch cultures.
Gain manufacturability information for downstream processing already during your candidate selection
Speaker: Frank Meyeroltmanns, Marketing Manager, Purification technologies, Sartorius Stedim GmbH, Germany
Manufacturability becomes more important in recent years as streamlining the process development is the only area where time to market can be optimized.Challenges like e.g. tendency to aggregate etc. of the selected candidate during the development of the downstream process can be time consuming especially during scale-up to secure a highly productive commercial manufacturing process.The ability to study some of this properties during the candidate selection will make the process development more predictive. ambr crossflow is a screening tool developed exactly for this purpose combined with early stage characterization and optimization. Minimal volume requirements provide the base to study the behavior of your candidate in multi-parallel experiments. Identifying the behavior under stress conditions like cross flow operations, different buffer condition, high concentrations and formulation will support decisions in the downstream development. In this technical presentation the working principles of the multi-parallel system and examples from real product condition will be presented.