Translating Stem Cell Programs to GMP: A Collaborative Approach to Overcoming Manufacturing Complexity

Stem cells are a powerful frontier in cell and gene therapy, offering pluripotency, self-renewal, and the ability to produce engineered, standardized therapeutic cell populations. iPSC platforms reduce donor variability and support scalable, consistent manufacturing for regenerative medicine, gene correction, and next-generation cell therapies. However, stem cell products are inherently process-defined: cell identity, function, potency, and safety are tightly linked to differentiation workflows, handling conditions, and manufacturing control. Even small process changes can significantly impact outcomes, increasing complexity as programs move toward GMP.

In this webinar, Meytal Haviv, a Process Development Scientist at Landmark Bio, will walk through common challenges teams encounter when advancing stem cell programs toward GMP, including RUO-to-GMP process redesign, operator-dependent variability risk, scaling limitations, raw material constraints, and analytical alignment with regulatory expectations. Drawing on real-world development experience, the discussion will focus on program design considerations and execution frameworks for process control, cross-functional coordination, tech transfer, and early GMP planning that influence reproducibility and risk as iPSC and stem cell programs move from development to clinic.

Key Learning Objectives:
Understand the unique process and scale challenges in stem cell manufacturing
Identify strategies to reduce variability and risk, improving GMP readiness
Collaborative approaches to translating stem cell processes from PD to GMP efficiently and successfully