Newark, New Jersey, January 17, 2022 – BioCentriq, Inc.—a New Jersey-based, cell and gene therapy contract development and manufacturing organization (CDMO)—announced today that they have successfully completed tech transfer of AVB-001 from client Avenge Bio and initiated manufacturing of clinical grade material, which will support Avenge Bio’s ongoing phase 1/2 clinical trial.
Sernova and Evotec on Track to Initiate Clinical Testing of First iPSC-Derived Islets as a Potential Functional Cure for Type 1 Diabetes
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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
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