June 2026– date –
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VIVEbiotech Scales In Vivo Gene Therapy Portfolio to 15 Programs, Securing Key FDA Clinical Trial Approvals
PharmaSource スペイン Overview Spanish CDMO VIVEbiotech has significantly expanded its in vivo lentiviral vector gene therapy portfolio to 15 programs, several of which have already secured regulatory clearance for clinical trials, inclu... -
Biomanufacturing Quality Control Transforms with Real-time PAT and AI Integration Under FDA ICH Q13 Guidance
Technology Networks UK Overview Process Analytical Technology (PAT) in biomanufacturing is undergoing a paradigm shift from endpoint testing to real-time, in-line measurement, driven by FDA's ICH Q13 guidance on continuous manufacturing,... -
Strategic CDMO Partnerships Accelerate in Cell and Gene Therapy Market to Tackle Manufacturing and Cost Challenges
Contract Pharma USA Overview The burgeoning cell and gene therapy (CGT) market is increasingly relying on strategic CDMO partnerships to navigate complex manufacturing and cost challenges. Sponsors are actively seeking CDMOs with special... -
CellShip® Method Preserves iPSC-Derived Cardiac Organoids for 7 Days at Room Temperature, Outperforming Cryopreservation
MDPI Switzerland Overview A novel room-temperature preservation method using CellShip® has successfully maintained the viability and functionality of human iPSC-derived cardiac organoids for up to seven days, significantly surpassing the... -
Heartseed Doses First Patient in Phase I/II EMERALD Study with iPSC-Derived Cardiomyocyte Spheroids HS-005 for Severe Heart Failure; Nikon CeLL innovation Provides Manufacturing Support
Heartseed Japan Overview Heartseed announced the successful dosing of the first patient in its Phase I/II EMERALD study for HS-005, an iPSC-derived cell therapy for severe heart failure. HS-005 consists of cardiomyocyte spheroids manufac... -
Century Therapeutics Unveils CNTY-813 iPSC-Derived Islet Replacement Preclinical Data at ADA 2026: Demonstrates Durable Glucose Control, Immune Evasion, and Scalable Manufacturing, IND Filing Expected Q4 2026
BioSpace (via GlobeNewswire) USA Overview Century Therapeutics presented new preclinical data for its iPSC-derived islet replacement therapy, CNTY-813, at the ADA 2026 Scientific Sessions. The data demonstrated durable glucose control, i... -
Preprint Reviews NKG2D CAR-NK Cell Progress in Cancer Immunotherapy: Low GVHD Risk, Scalable Manufacturing, and iPSC-Derived NK Cells as a Platform for Off-the-Shelf Therapies
Preprints.org International Overview A preprint on Preprints.org reviews recent progress in NKG2D CAR-NK cells for cancer immunotherapy, highlighting their favorable safety profile with rare instances of graft-versus-host disease (GVHD) ... -
MDPI Paper Analyzes Direct Cellular Reprogramming Advances and Challenges: Functional Transformation of Fibrotic Tissues vs. Safety and Efficiency Bottlenecks
MDPI Switzerland Overview A scholarly article in MDPI reviews advances in direct cellular reprogramming for regenerative medicine, highlighting its potential to transform fibrotic tissues into functional parenchyma. However, it criticall... -
Evotec Establishes GMP-Ready Automated 3D Stirred-Tank Bioprocess for iPSC-Derived Macrophages, Achieving Consistent Quality and High Yield
Evotec Germany Overview Evotec has announced the establishment of an automated, GMP-compliant 3D stirred-tank bioprocess for the scalable production of iPSC-derived macrophages. This innovative process suggests the capability to manufact... -
Cellares and TScan Therapeutics Partner to Automate Manufacturing of TCR-T Therapy Candidate TSC-101 for Hematologic Malignancies, Accelerating Commercialization
OTC Markets (BusinessWire) USA Overview Cellares and TScan Therapeutics announced an agreement to evaluate the automated manufacturing of TSC-101, a TCR-T cell therapy candidate for patients with hematologic malignancies. This collaborat...
