allogeneic– tag –
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Cell Therapy Clinical Success Hinges on Manufacturability: Limitations of Autologous Therapies Drive Interest in Allogeneic ‘Off-the-Shelf’ Platforms
Cell & Gene Unknown Overview Cell therapy scalability is a critical factor to consider from early development, as autologous therapies face challenges in manufacturing complexity, scheduling constraints, and inherent scalability limitati... -
FDA Approves Tregzi, First Regulatory T-Cell (Treg) Immunotherapy for Chronic GVHD Prevention, Expands Casgevy Indication to Pediatric Patients
Cell and Gene Therapy Catapult USA Overview On June 30, 2026, the U.S. FDA approved Tregzi, the first regulatory T-cell (Treg)-based immunotherapy designed to prevent chronic graft-versus-host disease (GVHD) and improve survival. Tregzi ... -
IPS HEART’s iPSC-Derived Cell Therapy ISX9-CPC Receives FDA Rare Pediatric Disease Designation for Muscular Dystrophy-Associated Cardiomyopathy
StreetInsider USA Overview IPS HEART, Inc. announced that its iPSC-derived cell replacement therapy, ISX9-CPC, has received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for cardiomyopathy associated with muscular dystrophi... -
Allogeneic CAR T-Cells: The Off-the-Shelf Revolution in Cancer Immunotherapy Manufacturing
Liv Hospital Turkey Overview Autologous CAR T-cell therapies face significant hurdles in scalability and turnaround time, limiting their broad accessibility. The industry is rapidly shifting towards off-the-shelf allogeneic CAR T-cells, ... -
XellSmart Secures FDA Fast Track Designation for Off-the-Shelf iPSC-Derived Cell Therapy XS411 for Parkinson’s Disease
BioSpace (XellSmart) USA Overview XellSmart announced that its allogeneic, off-the-shelf iPSC-derived cell therapy candidate, XS411, for Parkinson's disease has received Fast Track Designation (FTD) from the U.S. FDA. XS411 aims to repla... -
Washington University-Developed CAR-T Therapy for T-Cell Leukemia and Lymphoma Receives FDA Breakthrough Therapy Designation: Off-the-Shelf Approach Improves Access
Washington University School of Medicine in St. Louis USA Overview A cell-based immunotherapy developed by Washington University School of Medicine in St. Louis, designed to treat rare and aggressive T-cell acute lymphoblastic leukemia a... -
Fate Therapeutics’ iPSC-Derived CAR-T FT819 Shows Safety and Improved Skin Scores in Refractory Systemic Sclerosis Phase 1; Repligen Acquires BioLife Solutions for $1.5 Billion
DeciBio USA Overview July 2026 highlights in next-generation therapeutics include Fate Therapeutics' preliminary Phase 1 data for FT819, an iPSC-derived CD19-targeted CAR-T cell therapy for treatment-refractory systemic sclerosis, demons... -
Catalent Bolsters End-to-End CDMO Services for Autologous & Allogeneic Cell Therapies, Including iPSC Center of Excellence
Catalent USA Overview Catalent is enhancing its end-to-end CDMO manufacturing support and process development services for both autologous and allogeneic cell therapies, covering CAR-T, TCR, TIL, NK cells, and iPSC- and MSC-derived treat... -
Automated GMP Facility Launched, Supercharging Scalable Production for Off-the-Shelf Cell Therapies
Company Announcement / Specialized Media International Overview A new, state-of-the-art GMP facility dedicated to commercial-scale allogeneic cell therapy manufacturing has commenced operations. This facility leverages advanced automatio... -
BioInformant Details 2026 iPSC-Derived Cell Therapeutics Pipeline: Key Players Accelerate Clinical Development for Parkinson’s, Heart Failure, Cancer, and More
BioInformant USA Overview BioInformant's comprehensive report outlines the 2026 pipeline for iPSC-derived cell therapeutics, highlighting progress from key companies like Fate Therapeutics, BlueRock Therapeutics, FUJIFILM Cellular Dynami...
