NMDP BioTherapies Introduces Enhanced Cellular Materials for Allogeneic Cell Therapy Development
First of Its Kind Clinical-Grade Leukopak Now Facilitates Easier Regulatory Filing with Access to a DMF and Identification of Additional Characteristics Required to Qualify Cord Blood Units as Starting Material for Manufacture of Cell and Gene Therapies
MINNEAPOLIS– NMDP BioTherapies℠ formerly Be The Match BioTherapies, a leader in cell and gene therapy development support, unveiled substantial upgrades to its cellular starting material offerings, including incorporating a Drug Master File (DMF) with its rapid-delivery, standard GMP leukopak to simplify regulatory filings. The strategic enhancements to its suite are designed to address the evolving needs of the allogeneic cell therapy industry, emphasizing optimized delivery times, customizable options, and expanded capabilities. [Read more…]
Panasonic and Shinobi Therapeutics Partner to Develop Efficient and Cost-Effective iPS Cell Therapy Manufacturing Technology
Panasonic to create a closed-system manufacturing device based on Shinobi’s innovative iPS-T cell platform and cutting-edge research at Kyoto University
Partnership aimed at significantly broadening accessibility of cell therapies to patients on a global scale
SAN FRANCISCO and KYOTO, Japan, April 18, 2024 — Shinobi Therapeutics, a biotechnology company developing a new class of immune evasive iPS cell therapies, today announced a partnership with Panasonic Holdings Corp and Kyoto University’s Center for iPS Cell Research and Application (CiRA). Through this strategic collaboration, the organizations aim to engineer a novel manufacturing platform to produce iPS-T cell therapies more efficiently and at lower cost than is possible with currently available technology. [Read more…]
Patient Enrolment Completed in CYP-006TK Diabetic Foot Ulcer Clinical Trial
Melbourne, Australia; 8 April 2024 – Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce the completion of patient enrolment in its Phase 1 clinical trial of CYP-006TK in diabetic foot ulcers (DFU). [Read more…]
Aruna Bio Announces FDA Clearance of IND for Lead Program AB126, Enabling the First Exosome to Enter in Human Clinical Trials for a Neurological Indication
-Phase 1b/2a clinical trial in acute ischemic stroke expected to initiate in 1H 2024-
-Marks the first IND for Aruna’s platform with plans to expand AB126, an unmodified exosome derived from proprietary neural stem cells, to other neurological indications including amyotrophic lateral sclerosis-
-Proprietary in-house GMP production capabilities enable scalable, reproducible production of clinical-grade exosomes with high purity and uniformity; analytical methods and well-characterized assays established to ensure therapeutic consistency-
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