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 ExCellerateâ„¢ GMP iPSC Expansion Medium, Animal Free (CCM0036-GMP), supporting the development and manufacture of regenerative medicine and stem cell therapies. [Read more…]
Stem Cell News
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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 Companyâ„¢, 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 Krakatoaâ„¢ 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.
IN8bio Presents Positive Data Update from iPSC Platform at SITC 38th Annual Meeting
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This data represents a step forward in developing next-generation ‘off-the-shelf’ iPSC derived gamma-delta T cells. Our proprietary expansion methods are serum and feeder-free and have the potential to produce billions of iVδ1 T cells.
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IN8bio’s iVd1+ subtype cells have an expression profile linked to a low risk of cytokine release syndrome (CRS) and have shown strong cancer-killing abilities against various solid and liquid cancers.
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Showcases the capability to manufacture specific gamma-delta T cell sub-types using a process that can be scaled for GMP- manufacturing as a potentially ‘off-the-shelf’ platform for allogeneic cell therapy.
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