Developing an iPSC Therapy? Start with a Strategy Built for Scale

Developing iPSC-based therapies demands more than scientific ambition. It requires a strategic, technically rigorous approach that can carry you from early-stage research to GMP manufacture.

That’s where we come in.

We partner with iPSC developers to translate research protocols into robust, regulatory-aligned processes. Whether you’re working with early platform lines or navigating multiple differentiation pathways, our integrated team helps define your CMC strategy, optimise development, and deliver clinical material with confidence.

Even the strongest science can be derailed by early missteps. iPSC-based therapies are uniquely complex and require more foresight than most developers expect.

Here’s what we often see:

• Regulatory expectations vary across regions. What is acceptable for early trials may be rejected in later stages or by stricter authorities.

• Research-grade materials are often used in cell line development, risking contamination, poor traceability or full re-derivation.

• Critical process parameters are not well characterised, making scale-up unpredictable and increasing batch failure risk.

• Analytical methods are underdeveloped, leading to gaps in identity, potency or differentiation tracking.

• Poor tech transfer results in inconsistent execution, missed timelines and material waste.

• Facilities aren’t built to support the long culture times or partially open steps that iPSCs require.