Webinar: Scaling iPSC Therapies Without Scaling Variability
FUJIFILM Cellular Dynamics will present a practical framework for standardizing, automating and scaling iPSC-derived therapy manufacturing.
iPSC manufacturing introduces variability at nearly every stage, from cell banking and expansion through differentiation, purification, formulation and cryopreservation.
Automation can help, but automating a poorly understood or inconsistent process may simply reproduce that variability more efficiently.
In this webinar, FUJIFILM Cellular Dynamics will share a CDMO perspective on building scalable iPSC manufacturing processes across multiple therapeutic cell types. The presentation will examine how standardized starting materials, quality-by-design principles, progressive automation and modern facility infrastructure can prepare a process for clinical development and eventual commercial production.
What the presentation will cover
- Why iPSC starting material is one of the most important variables to standardize
- Using quality by design to connect critical quality attributes, process parameters and control strategies
- Moving iPSC expansion from manual culture vessels into scalable bioreactor workflows
- Applying automated cell counting, closed washing and concentration, and liquid-handling systems
- When to introduce automation during early, middle and late-stage development
- How closed processing can reduce contamination risk and cleanroom requirements
- Designing modular facilities that can accommodate multiple processes and emerging technologies
- Connecting equipment, process data, electronic records and real-time monitoring
- Future directions including adaptive process control and digitally integrated supply chains
Manufacturing case studies
The presentation will include examples from FUJIFILM Cellular Dynamics’ implementation of:
- PBS Biotech bioreactors for scalable cell expansion
- Cellaca MX for high-throughput cell counting
- Rotea for closed washing and concentration
- Tecan Fluent for automated iPSC differentiation development
Who should attend
Scientists and leaders working in:
- iPSC-derived therapy development
- Cell therapy process development and MSAT
- Manufacturing sciences and technology
- CMC and regulatory strategy
- Manufacturing automation
- Facility and process engineering
- Quality control and analytical development
Presenter
Stephen Fischer
FUJIFILM Cellular Dynamics
Register free to learn how iPSC developers can reduce process variability, introduce automation at the appropriate stage and build manufacturing systems capable of supporting future clinical and commercial scale.
