Background
Ncardia's innovative use of stirred tank bioreactors for HSC differentiation from iPSCs addresses the critical need for large batch consistency and scalability in cell therapy applications. By combining expertise in stem cell biology with advanced bioreactor technology, Ncardia ensures high-quality, reproducible HSC production with GMP compliant processes.A Design of Experiments (DoE) approach was employed to systematically evaluate critical process parameters (CPPs) such as dissolved oxygen, agitation speed, and inoculation density. Parallel testing of multiple differentiation protocols was conducted to establish proof of concept. In-process monitoring, combined with comprehensive data science analysis, enabled a robust understanding of critical quality attributes (CQAs).
This methodology ensures the optimization and consistency of the differentiation process, facilitating scalable and reproducible HSC production.
The iPSC-derived HSCs exhibited typical morphology, expressed key markers and showed potential for differentiation into multiple immune cell lineages, including natural killer (NK) cells and macrophages.
Key objectives:
- Learn strategies to mitigate risks and accelerate process development using advanced data science
- Discover how to easily incorporate GMP-compliant processes early in cell therapy development
- Understand how robust processes can boost confidence in the early stages of developing new therapeutics