Building a scalable iPSC manufacturing process from cell bank to bioreactor
Scaling induced pluripotent stem cell (iPSC) therapies for clinical and commercial demand requires cell biology and process development to advance together. Early decisions around cell banking, expansion, differentiation, bioreactor strategy, process control and automation can have a significant impact on future scalability and manufacturing readiness.
In this webinar, experts in cell technology and bioprocess engineering explore how to translate iPSC biology into a robust and scalable manufacturing process. Drawing on practical experience in GMP cell banking and scale-up to 50 L, the speakers discuss the transition from 2D culture to 3D expansion and differentiation in bioreactors, as well as critical considerations around seed-train design, hydrodynamics, feeding, monitoring and harvesting.
The session also explores how modeling and greater process understanding can help reduce scale-up risk and unnecessary biological runs. Learn why iPSC process development should work backward from target dose, patient demand and the future supply model to support reproducibility, manufacturing efficiency, cost and long-term capacity.
What you will learn:
- How to translate iPSC biology from 2D culture to scalable 3D bioreactor processes
- Key considerations for iPSC expansion and differentiation
- How seed-train design, hydrodynamics, feeding, monitoring and harvesting influence scale-up
- How modeling and process understanding can help reduce scale-up risk
- Why early process decisions influence reproducibility, manufacturing complexity, cost and capacity
- How target dose and patient demand can inform the future iPSC manufacturing and supply strategy
FAQs answered in webinar
What are the key considerations for scaling iPSC manufacturing?
Scaling iPSC manufacturing requires early planning around cell banking, expansion, differentiation, bioreactor strategy, process control and automation. These decisions can influence process reproducibility, manufacturing complexity, cost and the ability to meet future clinical and commercial demand.
How can iPSC manufacturing be scaled from 2D culture to 3D bioreactors?
Moving from 2D culture to 3D iPSC expansion and differentiation in bioreactors requires careful consideration of seed-train design, hydrodynamics, feeding strategies, monitoring and harvesting. Cell biology and bioprocess engineering must be developed together to maintain cell quality while increasing scale.
Why is GMP cell banking important for scalable iPSC manufacturing?
A robust GMP cell banking strategy provides a consistent starting material for iPSC manufacturing and supports greater reproducibility as production scales. Establishing the cell banking approach early can also help prepare a therapy for future clinical and commercial manufacturing requirements.
What are the main challenges when scaling up an iPSC bioreactor process?
Key challenges in iPSC bioreactor scale-up include maintaining the appropriate hydrodynamic environment, designing an effective seed train, optimizing feeding and monitoring, and developing reliable harvesting strategies. These factors must be balanced with the biological requirements of the cells.
How can process modeling reduce risk during iPSC scale-up?
Process modeling and improved process understanding can help predict how operating conditions may change as iPSC manufacturing moves to larger bioreactors. This can guide process design, identify potential scale-up risks and reduce the need for unnecessary biological runs during development.
What should you look for in a CDMO for iPSC manufacturing and scale-up?
When selecting a CDMO for iPSC manufacturing, developers should consider expertise across GMP cell banking, iPSC expansion and differentiation, bioreactor scale-up, process development and manufacturing readiness. Lonza’s experience in GMP cell banking and iPSC scale-up to 50 L can help developers consider manufacturability and future supply needs earlier in process development.
