Specifically, the guidance recommends conducting analytical comparability studies to provide scientific evidence of the impact that manufacturing changes may have on the safety, potency, and purity of human cellular and gene therapy products...
Artiva Biotherapeutics announced today that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application for AlloNK®, in combination with rituximab for treatment of systemic lupus erythematosus in patients with active lupus nephritis...
A form of gene therapy currently used to treat Parkinson’s disease may dramatically reduce alcohol use among chronic heavy drinkers, researchers at Oregon Health & Science University and institutions across the country have found...
In a promising form of immunotherapy known as CAR T-cell (chimeric antigen receptor) therapy, the patient’s T cells are engineered to better recognize and attack antigens on the surface of cancer cells. In treatments currently approved for use in battling lymphoma and leukemia...
The U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current...
As the field of advanced cell and gene therapies continues to grow exponentially, ensuring their safety and efficacy becomes paramount. Biodistribution studies, which evaluate the distribution of viral vectors and transgenes in the body, play a crucial role in pre-clinical pharmacokinetics and toxicity assessments...
Sarepta Therapeutics announces FDA approval of ELEVIDYS, the first gene therapy to treat Duchenne Muscular Dystrophy. ELEVIDYS addresses the root genetic cause of Duchenne – mutations in the dystrophin gene that result in the lack of dystrophin protein – by delivering a gene that codes for a shortened form of dystrophin to muscle cells known as ELEVIDYS micro-dystrophin...
2seventy bio announced new data featuring novel approaches combining the company’s platform CAR T cell and T cell receptor technology and unique cell therapy engineering capabilities to potentially enhance treatment potency in a range of cancers...
Ensure the Success of Your Cell Therapy Drug Development - Avance Provides Assays to Support your Biopharmaceutical Development & Manufacturing - Avance Biosciences™ is a world-leading CRO specializing in GLP & GMP compliant biological assay development, assay validation, and [...]
Preclinical data demonstrates that hypoimmune-modified allogeneic iPSCs evade immune response and rejection without immunosuppression in a non-human primate model and long-term survival and immune evasion was at least equivalent to the survival of autologous iPSCs...
