Catalent Opens Cell Therapy Manufacturing Facilities in Belgium

Catalent has announced the completion and opening of one of the world’s largest commercial-scale cell therapy manufacturing facility at its European center of excellence for cell therapies, in Gosselies, Belgium. Article Summary The new facility is established with 60,000 square feet (5,600 square meters) of dedicated cell therapy manufacturing space housing multi-product, segregated suites designed […]

Thermo Fisher Scientific Introduces All-in-One AAV Production System

The Gibco CTS AAV-MAX Helper-Free AAV Production System, a new all-in-one solution from Thermo Fisher Scientific, has been developed to help fulfil clinical and business demands for the affordable and scalable production of adeno-associated virus (AAV)-based gene treatments. It is currently the only product of its kind to be produced following cGMP guidelines in order […]

Researchers at University Hospitals Seidman Cancer Center and a Biotech Start-Up Company Streamline Way to Manufacture CAR T-cells for Immunotherapy Treatment in 24 Hours

A simplified method for producing CAR T-cells for immunotherapy treatment in just 24 hours has been devised by researchers at University Hospitals Seidman Cancer Center and a biotech start-up business. Article Summary This ground breaking new development will expedite the delivery of CAR T therapy to those who need it most. Researchers stated that the […]

Kriya Acquires Redpin Therapeutics, Adding Neurology Pipeline to Gene Therapy Portfolio

Kriya Therapeutics, Inc., a fully integrated gene therapy company with a wide range of portfolio of innovative therapeutics, has announced the acquisition of Redpin Therapeutics, Inc., a private biotechnology company developing regulatable gene therapies for intractable diseases of the nervous system. Article Summary The acquisition serves as the foundation for Kriya’s neurology therapeutic area portfolio, […]

BioLineRx Received US FDA Approval for NDA for APHEXDA® (motixafortidenew ) in Stem Cell Mobilisation

BioLineRx Ltd, a pre-commercial-stage biopharmaceutical company has announced that the U.S. FDA has accepted for review and filed the Company’s New Drug Application (NDA) for APHEXDA® (motixafortide) in stem cell mobilization for autologous transplantation in multiple myeloma patients. Article Summary Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for several blood […]

Thermo Fisher Scientific Unveils Closed and Automated Cell Isolation and Bead Removal System to Help Evolve Cell Therapy Manufacturing

Excerpt Thermo Fisher Scientific Inc. has unveiled the Gibco™ CTS™ DynaCellect™ Magnetic Separation System (DynaCellect) to help cell therapy developers easily move from process and clinical development to commercial manufacturing.  Article Summary This next-generation cell isolation, cell activation, cell depletion and Dynabeads™ magnetic beads removal instrument provides a scalable, flexible, automated and closed system to […]

Scribe Therapeutics Announces Research Collaboration with Sanofi to Accelerate Breakthrough CRISPR-based Cell Therapies for Cancer

Excerpt Scribe Therapeutics Inc., a molecular engineering company pioneering a CRISPR by Design™ platform for genetic medicine, has announced a strategic collaboration with Sanofi to grant the non-exclusive license to Scribe’s CRISPR genome editing technologies that can enable genetic modification of novel natural killer (NK) cell therapies for cancer. Article Summary The agreement grants Sanofi […]

Kite’s Yescarta First CAR T-cell Therapy to Receive European Marketing Authorization for Use in 2nd Line B-cell Lymphoma

Excerpt Kite, a Gilead Company has announced that the European Commission (EC) has granted approval for the use of Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. Article Summary […]

Gene Therapy Trial Starts for Parkinson’s Disease by Researchers in Japan

Researchers of Jichi Medical University Hospital in Japan have started a trial of a treatment for Parkinson’s disease by injecting genes into a patient. This is reportedly the first clinical trial of this treatment method in the country. Article Summary The team has injected the genes directly into a male patient’s brain, with the aim […]

WhiteLab Genomics is Using AI to Aid Gene and Cell Therapy Development

French biotech company WhiteLab Genomics has raised $10 million in funding for an AI platform designed to aid the discovery and development of genomic therapies. WhiteLab Genomics provide gene and cell therapy companies with predictive software simulations to expedite the design of gene and cell therapies. Article Summary As with just about any AI models, […]

FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

The U.S. Food and Drug Administration and the National Institutes of Health (NIH) has announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases. The […]

Bluebird Bio Receives FDA Accelerated Approval for SKYSONA® Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)

Bluebird bio, Inc. has announced the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of SKYSONA® (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). The Company also confirmed that the previous clinical hold on the eli-cel […]