Closed, Automated and Controlled Upstream Processing for iPSC- Derived Cell Ther - Seguridad Mania.com - España y América Latina

In this presentation we will discuss these challenges and potential solutions presenting case studies where utilising closed and automated single use hollow-fibre bioreactors enables robust and scalable 2D expansion of iPSC cells whilst maintaining pluripotency supporting scale-up and scale-out of iPSC-derived cell therapies. We also show improved intensification of iPSC expansion in single use stirred-tank bioreactors achieving high cell densities and combine this with novel systems for undertaking closed and semi-automated media exchange and passage supporting scale-up and reducing cost of goods making for truly cost-effective off-the-shelf therapies. We discuss the utility of novel process analytical technologies for monitoring iPSC expansion and differentiation in-line and their utility in driving manufacturing decisions enabling better control and reduced risk of failure for these prolonged processes especially in a context where traditional methods for monitoring cannot be applied when at scale and in closed bioreactors. In conclusion, this presentation will highlight the key cell culture and upstream processing challenges in industrialisation of iPSC-derived cell therapies and present case studies on solutions that provide controlled, closed and automated manufacture that supports adoption of potentially transformative off-the-shelf iPSC derived cell therapies.