Closed, Automated and Controlled Upstream Processing for iPSC- Derived Cell Therapies


19th November 2020 | 10:00 am EST | Mustafa Munye, Lead Scientist at Cell and Gene Therapy Catapult |BOOK FREE SEAT FOR THIS WEBINAR

Induced pluripotent stem cells (iPSC) offers a renewable source for reliably and robustly generating off-the-shelf cell products for regenerative medicine through to cellular immunotherapies including iPSC derived NK and CAR-T therapies. Since their discovery in 2006 robust differentiation protocols have been developed and PSC-derived cells have been used in a variety of animal models to treat different diseases and progressed through to clinical trials in Asia and more recently the United States. However, the manufacturing processes for expansion and differentiation of iPSC cells remain reliant on manual, open and poorly scalable technologies with limited in process monitoring despite typically > 7 days of culture and manipulation required increasing the risks and costs of batch manufacturing failure. 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.

 

Presented by Mustafa Munye, Lead Scientist at Cell and Gene Therapy Catapult


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