Out-Licencing Program Supports Diabetes Treatment Progression

Danish spin-out PanCryos has reached a licensing agreement with Takara Bio Europe AB (TBEAB) surrounding its clinical-grade human embryonic stem (hES) cell lines. PanCryos has established a simplified and effective method to generate stem cell-derived, glucose-responsive beta cells and is one of several customers in TBEAB’s new out-licensing program, which enables industrial partners to use the clinical-grade hES cells to develop and commercialise breakthrough cell therapy products for previously unmet indications.

PanCryos, a spin-out arising from the Novo Nordisk Foundation Center for Stem Cell Biology (DanStem) at the University of Copenhagen, is aiming to develop a next generation stem cell derived allogeneic cell therapy (PanINSULA™) for type 1 diabetes. Jacqueline Ameri, CEO said: “We are very hopeful that our extensive scientific and industry expertise, combined with TBEAB’s expertise in clinical-grade hES cell production, will put us in a position to take the crucial next step in the development of our best-in-class, commercially sustainable PanINSULA™ cell therapy for type 1 diabetes.”

The derivation work and scale-up for TBEAB’s clinical-grade hES cell line were conducted with feeder-free and xeno-free culture conditions under a manufacturing license granted by the Swedish MPA at the company’s GMP manufacturing facility in Göteberg, Sweden.

“To our knowledge, this is the first human ES cell line that was derived under GMP conditions based on starting material sourced from prion-free countries and where the donors were tested within 7 days of the retrieval of the starting material according to FDA’s requirement,” said Kristina Runeberg, Site Head and Senior Director, Business Development at TBEAB. “We take pride in our rigorous quality and safety standards and our customers know they can rely on us for high-quality, safe starting material for their cell therapy development.”

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