Scaling iPSC-derived therapies to GMP: lessons from immune and regenerative medicine programs

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Scaling iPSC-derived therapies to GMP: lessons from immune and regenerative medicine programs

Moving an iPSC-derived process from bench to GMP means new equipment, new qualified raw materials, and new operators, and any one of these can break comparability with what worked in development. This webinar draws on real GMP process development and tech transfer work across both immune (NK and T cell) and regenerative medicine (cardiac cell) programs to show how two early decisions, manufacturing platform selection and raw material qualification, determine whether a scaled process holds up. Attendees will see how linking critical process parameters to critical quality attributes allows teams to catch comparability risks before they surface as a failed batch.

Attend this webinar to:

Learn how manufacturing platform selection and raw material qualification shape every downstream outcome in GMP scale-up, illustrated across immune and regenerative medicine iPSC programs
See real examples linking critical process parameters (CPPs), such as stirring speed and oxygenation, to CQAs including intermediate cell identity, to predict and diagnose comparability issues
Understand what stays consistent and what changes when scaling different iPSC-derived cell types, and where segment-specific risk emerges
Gain a practical framework for evaluating platform and raw material choices before committing to a scale-up strategy, rather than after a batch fails

Stefan Braam

Chief Technical Officer at Cellistic

Stefan Braam is the co-founder and Chief Technical Officer of Cellistic and its affiliate company, Ncardia. Stefan brings Cellistic over a decade of experience in stem cell technology, product development and general management.

He co-founded Pluriomics/Ncardia in 2011, and, as the inventor of its core technologies, has been instrumental in the establishment and growth of the organization. Stefan earned a MSc and PhD (both cum laude) in stem cell biology under supervision of Prof. Dr. C.L. Mummery and obtained international experience in labs in the UK and Australia.

Stefan won the NGI venture challenge (2009), the Niaba biobusiness Masterclass (2010), published in multiple leading scientific journals, is an inventor on multiple patent families, secured multiple grants and commercial research collaborations and was instrumental in Ncardia pre-seed, seed, Series A and B financing rounds.

Anne-Sophie Lebrun

MSAT Director at Cellistic

Anne-Sophie leads Cellistic’s Manufacturing Science and Technology (MSAT) department, ensuring the translation of processes from development into GMP manufacturing. She brings to the team extensive experience in operations, technology transfer, and process industrialization within advanced therapy environments.

Before joining Cellistic, Anne-Sophie spent several years at Bone Therapeutics (now BioSenic), where she held leadership roles across manufacturing, process optimization, and program management, ultimately serving as Chief Operating Officer. She also worked as a consultant at Amaris, supporting life science organizations in technical and operational projects.

Anne-Sophie holds a PhD in Molecular Biology from UCLouvain, where her research focused on the functional and structural characterization of plant aquaporins.

In 54 Days

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