In this Q&A, Stefan Braam (SB), Chief Technical Officer at Cellistic, talks to Dr Kevin Robinson (KSR) about the technical bottlenecks and manufacturing innovations required to bring induced pluripotent stem cell (iPSC) platforms to the global market.
KSR: What is driving the renewed momentum behind off-the-shelf allogeneic cell therapies and how is this shift influencing the way developers approach manufacturing strategy from the outset?
SB: We are now two decades into iPSC technology and have reached a clinical inflexion point, with real-world validation emerging. Japan recently granted provisional market approvals for iPSC-derived Parkinson’s and cardiac products … and pivotal trials are underway for other indications.
This clinical success is prompting developers to take a more strategic approach to manufacturing. Previously, the focus was simply on proving the therapy worked.
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