MADISON, WI, January 23, 2024 — FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cells (iPSC), and Opsis Therapeutics, LLC, a joint venture of FUJIFILM Cellular Dynamics and co-founder David Gamm, M.D., Ph.D., focusing on developing cell therapies for patients with ocular diseases, today announced an agreement granting BlueRock Therapeutics (Cambridge, Mass.) an exclusive, worldwide license to develop and commercialize an iPSC-derived cell therapy candidate for the treatment of human retinal diseases. BlueRock Therapeutics, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, exercised its option to exclusively license OpCT-001, an iPSC-derived photoreceptor cell therapy for human retinal diseases. [Read more…]
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Bio-Techne Files Drug Master File For ExCellerate GMP iPSC Expansion Medium to Support Manufacture of Stem Cell Therapies
MINNEAPOLIS, MN, December 20, 2023 — Bio-Techne Corporation (NASDAQ: TECH) has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCellerate™ GMP iPSC Expansion Medium, Animal Free (CCM0036-GMP), supporting the development and manufacture of regenerative medicine and stem cell therapies. [Read more…]
Core Biogenesis and Nucleus Biologics Announce Strategic Collaboration for Manufacturing and Distribution of Cost-Effective and Sustainable Recombinant Proteins
San Diego, CA, January 10, 2024 – In a joint effort to provide lower cost and more defined reagents and media to the cell and gene therapy market, Nucleus Biologics, The Cell Performance Company™, a leading provider of custom cell culture media solutions for the cell and gene therapy industry, has signed a manufacturing, distribution, and collaboration agreement with Core Biogenesis, an innovator in the field of recombinant human proteins expressed in plants. This agreement makes Nucleus Biologics the GMP manufacturer for Core Biogenesis’ recombinant proteins and a distributor for the cell and gene therapy market. In addition, Nucleus Biologics, along with their sister company Stoic Bio, will make these recombinant proteins available for their Krakatoa™ pod-based media manufacturing systems. [Read more…]
BioCentriq® Strengthens Cell Therapy CDMO Services with $29.2M in Capital Investment
NEWARK, N.J., — BioCentriq®, a global cell-based therapy Contract Development and Manufacturing Organization (CDMO), proudly announces the successful completion of its latest round of fundraising, securing $29.2M in capital investment. The funding round marks a significant milestone in BioCentriq’s mission to accelerate delivery of innovative cell therapies by translating, optimizing, and scaling processes for GMP manufacture. [Read more…]
MESOBLAST Achieves First Ever U.S. FDA Approval of an MSC Therapy (RYONCIL®)
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RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication.
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In a single-arm, multi-center, Phase 3 trial of children with steroids-refractory (SR) acute GvHD, 70% achieved an overall response by Day 28 of treatment with RYONCIL, a measure that predicts survival.
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RYONCIL’S immunomodulatory effects, including inhibition of T cell activation and secretion of pro-inflammatory cytokines, position the therapy for potential other indications in diseases with excessive inflammation.
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