In this webinar, we share what it takes to move an iPSC-derived therapy from the bench to GMP manufacturing, drawing on lessons from our immune and regenerative medicine programs. We present a three-step framework for designing scalable, compliant, and cost-effective processes, and we apply it to two case studies: iPSC-derived cardiomyocytes and a hematopoietic cell therapy product.
Highlights of the webinar:
- Why early CMC decisions determine cost of goods, scalability, and regulatory readiness for iPSC-derived therapies
- A three-step framework for scalable processes: know your cells, understand your constraints, and design for predictability at scale
- Echo™-Cardio case study: a cytokine-free stirred-tank bioreactor process delivering 82% cTnT+ cardiomyocytes at harvest
- Hematopoietic case study: moving from open T-flasks to a closed, scalable process, with about 100-fold higher yield and 200 doses filled in one run