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…]
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.
FluidForm Bio Demonstrates Advancements in Engineered Heart Tissues Using iPSC-derived Cardiomyocytes with FRESHâ„¢ 3D Bioprinting
WALTHAM, Mass. — FluidForm Bio, a leader in developing life-like human tissue to treat disease, shares recent advancements in building human cardiac tissues using FRESHâ„¢ 3D bioprinting. Recently published in APL Bioengineering, the research article FRESHâ„¢ 3D bioprinted cardiac tissue, a bioengineered platform for in vitro pharmacology addresses the critical need for a predictive model of human cardiac physiology in drug development. There are significant gaps in existing models due to their incomplete recapitulation of adult human cardiovascular physiology. FluidForm Bio has demonstrated potential for bridging this gap using human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) in three-dimensional tissue structure. [Read more…]
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