Compliance by Design – Lessons Learned from Creating GMP-Compliant iPSCs for Use in Cell Therapies and Patient Treatments

3:10 pm - Wednesday 9th September 2026

  • Highlighting key challenges and practical solutions for advancing iPSC‑based cell therapies and demonstrates how strategic partnerships can streamline access to enabling technologies, high‑quality starting materials, and scientific and regulatory expertise
  • Sharing key lessons learned from developing robust iPSC manipulation workflows, addressing donor‑related considerations, and building data packages that meet health authority and regulatory expectations
  • Finally, it demonstrates how coupling GMP‑grade iPSC lines with efficient downstream manufacturing platforms, within a partnership‑driven model, can accelerate progression from early development through late‑stage and commercial manufacturing

Speakers:

Vice President, Corporate Innovation
Catalent, Inc.