Overcoming Scale-Up Challenges in iPSC Production: A Joint Investigation by PBS Biotech and Carr Biosystems
Abstract
Successful commercialization of induced pluripotent stem cell (PSC)–derived therapies requires robust, large‐scale cell processing operations – including expansion, differentiation, harvest, and concentration - that preserve critical cell attributes at every step. Although recent advances have enabled scalable PSC expansion, efficient downstream cell processing solutions for PSC aggregates remain underdeveloped. Preserving PSC aggregate properties is essential for bioreactor-to-bioreactor passaging in differentiation seed trains and for establishing high-quality PSC banks for downstream manufacturing. Closed, low-shear, automated processing technologies are therefore needed to safeguard cell viability, ensure reproducibility, and enable industrial scalability across all production stages.
Key Takeaways
- Carr Biosystems tubular bowl centrifugation platform coupled with Vertical-Wheel bioreactors yield 90% iPSC cell recovery and 95% cell aggregate viability for industrial scale manufacturing of iPSC-derived therapies
- Overcome challenges with preserving iPSC aggregate uniformity and viability scaling from 60ml to 80L working volumes
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