The Danish spin-out PanCryos has signed a license agreement with Takara Bio Europe AB (TBEAB) for its clinical human embryonic stem cell lines (hES). PanCryos has established a simplified and effective method for generating stem cell-derived, glucose-responsive beta cells and is one of several customers in TBEAB’s new out-licensing program, with which industrial partners use the clinical hES cells for development and commercialization can provide groundbreaking cell therapy products for previously unmet indications.
PanCryos, a spin-out from the Novo Nordisk Foundation Center for Stem Cell Biology (DanStem) at the University of Copenhagen, aims to develop a next generation allogeneic stem cell therapy (PanINSULA ™) for type 1 diabetes. Jacqueline Ameri, CEO, said, “We are very confident that our extensive scientific and industrial expertise combined with TBEAB’s expertise in producing clinical grade HES cells will enable us to do the most important thing take the next step in developing our best products. first-class, commercially sustainable PanINSULA ™ cell therapy for type 1 diabetes. “
The derivation work and scale-up for TBEAB’s clinical hES cell line was carried out under feeder-free and xeno-free culture conditions under a manufacturing license issued by the Swedish MPA at the company’s GMP manufacturing facility in Göteberg, Sweden.
“To the best of our knowledge, this is the first human ES cell line that has been obtained under GMP conditions from raw material from prion-free countries and in which the donors were tested within 7 days of the original material being collected in accordance with the requirements of the FDA. ”Said Kristina Runeberg, Site Manager and Senior Director Business Development at TBEAB. “We pride ourselves on our strict quality and safety standards and our customers know that they can rely on high-quality and safe starting materials when developing their cell therapy.”
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