Drew Hope, our Senior Compliance Consultant and UK QP, shares his insights on the regulatory and technical challenges surrounding induced pluripotent stem cell (iPSC) therapy development, and why early CMC strategy is critical.
Aug 13, 2025
Rethinking iPSC Development: Why Adopting an Early CMC Strategy is Essential
In this article for Cell & Gene Therapy Review, Drew explains how many iPSC programmes fail to reach the clinic not due to scientific shortcomings, but because of under-planned materials sourcing, inconsistent application of GMP principles, and delayed regulator engagement.
From cell line development (CLD) through to Quality Target Product Profile (QTPP) planning, the piece highlights where developers can go wrong and how to anticipate regulatory complexity from the outset. The message is clear: a robust CMC plan cannot be retrofitted later.
“For developers aiming to bring iPSC-based therapies to the commercial market, the starting point is not the laboratory bench, it is the strategic plan.”
Key takeaways from the article include:
- iPSC-derived therapies face significant regulatory uncertainty, especially during early-stage cell line development.
- Delaying CMC strategy planning can lead to rework, rejected applications or territorial restrictions.
- Developers should apply quality risk management and GMP principles from the outset — even in research settings.
- Early consultation with regulators is essential, especially when deviating from full GMP.
- A platform-based iPSC approach adds complexity, making early control even more critical.
If you’re working on an iPSC-based therapy, this article offers practical insights to help reduce risk, improve regulatory alignment and set your development on the right path.
Read the full article in Cell & Gene Therapy Review: Rethinking iPSC Development: Why Adopting an Early CMC Strategy is Essential
For further reading, explore our related blog post on iPSC CMC strategy and development.
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