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 First iPSC-derived commercially viable off-the-shelf islet combination product is advancing towards regulatory filing in 2024 for anticipated clinical trial authorization to treat patients with Type 1 Diabetes (T1D) and severe hypoglycemia
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iPSC islet-like cluster manufacturing scale-up and tech transfer activities are well under way in preparation for first human clinical evaluation
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T1D preclinical models with iPSC derived islet clusters transplanted in Sernova’s Cell Pouch has now demonstrated consistent long-term insulin independence de-risking the combined technologies for both companies
Sartorius collaborates with RoosterBio to advance downstream purification processes for the manufacture of exosomes
Through this collaboration, Sartorius and RoosterBio will provide best-in-class solutions and expertise for a human mesenchymal stem/stromal cell (hMSC) – based exosome production platform that delivers industry-leading yield, purity, and potency.
FREDERICK, Md., Jan. 5, 2023 – The life science group Sartorius extended a strategic collaboration partnership agreement with RoosterBio Inc. (RoosterBio) to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies. Through this collaboration, Sartorius and RoosterBio will provide best-in-class solutions and expertise for a human mesenchymal stem/stromal cell (hMSC) – based exosome production platform that delivers industry-leading yield, purity, and potency. [Read more…]
FUJIFILM Cellular Dynamics Announces License Agreement with Novo Nordisk for the Development of iPSC-Derived Cell Therapies
MADISON, WIS., January 5, 2023 – FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cells (iPSC), announced that it has entered an agreement to grant global healthcare company Novo Nordisk A/S a non-exclusive right to use FUJIFILM Cellular Dynamics’ iPSC platform for the development and commercialization of iPSC-derived cell therapies with a focus on addressing serious chronic diseases. [Read more…]
European Approval Makes Atara’s Ebvallo™ First Allogeneic T-Cell Therapy Approved Worldwide
Atara Biotherapeutics’ Ebvallo™ (tabelecleucel) Receives European Commission Approval as First Ever Therapy for Adults and Children with EBV+ PTLD
Represents First Approval of an Allogeneic T-Cell Immunotherapy Globally
Pierre Fabre to Lead Commercialization and Distribution Activities in Europe
I Peace, Inc. honored in BioSpectrum Asia Excellence Award 2022 with “Special Recognition in Cell Therapy”
PALO ALTO, Calif., Dec. 21, 2022 — I Peace, Inc. has been awarded a “Special Recognition in Cell Therapy” during BioSpectrum Asia Excellence Award 2022 ceremony held in Singapore on December 2.
I Peace, Inc. is a Palo Alto-based biotech company focusing on Nobel Prize-winning technology of induced pluripotent stem cells (iPSCs) and has successfully developed a novel system to mass manufacture clinical-grade iPSCs for cell therapy in a palm-sized closed cassette. I Peace supports research institutions and pharmaceutical companies around the globe by providing clinical-grade iPSCs conforming with regulatory standards both in the U.S. and Japan. [Read more…]
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