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Göteberg, Sweden – May 05, 2021 – Life Science Newswire – Takara Bio Europe AB (TBEAB) and PanCryos are pleased to announce that they have reached a licensing agreement surrounding TBEAB’s 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 commercialize breakthrough cell therapy products for previously unmet indications. Jacqueline Ameri, CEO of PanCryos 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.”
This announcement comes following TBEAB’s successful establishment of a new clinical-grade hES cell line. The derivation work and scale-up were conducted with feeder-free and xeno-free culture conditions under a manufacturing license granted by the Swedish MPA at TBEAB’s state-of-the-art 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.”
The out-licensing program is the newest addition to TBEAB’s ever-expanding portfolio of solutions, including services and GMP-grade media, that support cell therapy applications in Europe. These products and services are also available in North America through TBEAB’s affiliate Takara Bio USA, Inc. Learn more about TBEAB’s clinical-grade hES cell line derivation capabilities here.