There were 168 Advanced Therapy Medicinal Product (ATMP) trials ongoing in the UK in 2021, compared to the 154 studies reported the previous year, a 9% increase, finds a new report.
Finnish company, Biovian Oy, has been engaged by a South Korea biotechnology company to carry out process development and manufacturing of an AAV-based innovative drug candidate.
PerkinElmer’s Sirion Biotech business is teaming up with the Centre for Genomic Regulation (CGR) to jointly develop new generation adeno-associated virus (AAV) vectors for type 1 and type 2 diabetes gene therapy in the pancreas.
Planning for Institutional Biosafety Committee (IBC) oversight is a critical and often neglected initiation step for human gene transfer (HGT) clinical research, says an expert.
Polyplus, a provider of transfection reagents, has acquired e-Zyvec, a France-based provider of DNA design and production services for tailor-made DNA vectors to expand expertise in plasmid DNA vector engineering.
Contract packaging and clinical supply services company Sharp has completed the construction of new purpose-built production suites to facilitate the packaging, storage and distribution of gene therapies at its facility in Heerenveen, The Netherlands.
Netherlands-based gene therapy company, VectorY Therapeutics, and Wageningen University have signed a strategic collaboration agreement for the development of novel baculovirus-based AAV production technologies.
Andelyn Biosciences says the FDA's acceptance of its GMP plasmid DNA drug master file (DMF) enables the CDMO to vertically integrate its clients’ manufacturing process, condensing timelines for developers to begin manufacturing to just three months....
There is a healthy appetite for continued investment in gene therapy, in new modalities and more indications, says an industry insider as he reflected on the prospects for the US gene therapy sector next year.
LEXEO Therapeutics, a clinical-stage gene therapy company, is partnering with CDMO, Fujifilm Diosynth Biotechnologies (FDB), to support the development and manufacturing of its AAV-mediated gene therapies.
VGXI, Inc, a provider of plasmid DNA manufacturing and development services, says multiple construction milestones have been reached for its new headquarters and manufacturing facility in Texas.
Fujifilm Irvine Scientific Inc has started the commissioning phase of its new 250,000 square feet (22,800 square meter) cell culture media manufacturing facility in Tilburg, the Netherlands; the site joins existing plants in the US and Japan.
CEOs at large pharma and biotech companies are upbeat when it comes to their outlook for both their own company and the industry at large; they also have a healthy appetite for M&A, found a KPMG survey.
ViroCell Biologics and Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) have formed a new partnership to immediately address the global viral vector manufacturing bottleneck for clinical trials
This month sees the launch of a new gene therapy player, Opus Genetics, a company backed and spun out by leading patient group Foundation Fighting Blindness’ venture arm, the Retinal Degeneration Fund (RD Fund).
Boston-based company, Vertex, has signed a deal to use Arbor Biotechnologies’ CRISPR gene-editing technology to develop novel cell therapies for the treatment of serious diseases.
Bluebird’s Lenti-D, or elivaldogene autotemcel, has won approval from the European Commission to treat children with a rare neurodegenerative disease called early cerebral adrenoleukodystrophy (CALD).
Bayer owned CDMO, Viralgen, has expanded its AAV vector manufacturing capabilities in San Sebastian, in the Basque region of Spain, with the opening last week of a new site.
Cobra Biologics, the gene therapy division of the Charles River owned Cognate BioServices, and Sweden's CombiGene recently announced the successful production and quality assurance of the plasmids to be used in the GMP production of the gene therapy,...
Biogen and Ginkgo Bioworks say their collaboration and license agreement will develop a next-generation AAV production platform, aiming to ‘redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors’.
Gamma Biosciences has taken a controlling investment in Mirus Bio, an innovator and developer of biomimetic, cell-adaptive lipid-polymer nanocomplexes (LPNCs) for nucleic acid delivery based in Wisconsin in the US.
Protalix BioTherapeutics is planning to propose a virtual or record review inspection to clear the barrier to approval of its Chiesi Farmaceutici-partnered Fabry disease treatment.
SparingVision will acquire GAMUT Therapeutics, the biotech behind a gene-independent approach to treat the later stages of rod-cone dystrophies such as retinitis pigmentosa (RP).
The UK has a strong genetics research base: but to date, academics have found it difficult to progress gene therapy research into clinical trials and beyond. The Sheffield Gene Therapy Innovation and Manufacturing Centre (GTIMC) is one of three new hubs,...
New York based, Neurogene, has announced a research collaboration with the University of Edinburgh for the development of a multiple-platform approach to diseases not addressable by conventional gene therapy.
UK biotech, OXGENE, says its SLIM platform for discovery of antibodies against membrane proteins in their native configuration in mammalian cells could support CAR-T therapeutics.
Tokyo headquartered, Fujifilm Corporation, has announced a new US$2bn (£1.4bn/€1.5bn) investment to establish a new large-scale biopharma site in the US.
Janssen Pharmaceuticals, Inc. has acquired the rights to Hemera Biosciences’ investigational gene therapy HMR59: which has been designed to help preserve vision in patients with severe age-related macular degeneration (AMD).
Special Edition: The Future of Continuous BioProcessing
Erbi Biosystems recently raised US$3.8m in a round led by Jaguar Biotech; the funds will allow the company to expand its platform of microfluidic bioprocess and bioreactor equipment, which is said to enable ultra-high cell density and continuous processing.
A neuroprotective drug which is already in development may be particularly effective for MND patients carrying a newly discovered genetic risk factor, helping to halt progression or even prevent the onset of the devastating degenerative disease.
The future of treatment for many of the most challenging diseases in the world is said to reside in personalized cell and gene therapy (CGT). These expensive and complex therapies have proven highly effective in multiple cases, but a challenge remains...
A panel discussion at the Reuters Events' Cell & Gene Therapy Conference USA 2020 looked at the key challenges in the cell and gene therapy (CGT) space, namely affordability and access, and how to circumvent those.
Novartis has acquired Vedere Bio, giving the company a new platform for AAV-based delivery of gene therapies and an optogenetics program for the treatment and prevention of vision loss and blindness.
Bayer will broaden its innovation base in cell and gene therapy with the acquisition of Asklepios BioPharmaceutical (AskBio): a US biotech working in gene therapies across different therapeutic areas.
Scientists have used gene therapy and a newly developed light-sensing protein to restore sight in mice: with the technology to start clinical trials in the US later this year.
US company, Dyno Therapeutics, has inked a deal with Roche to develop next-generation AAV gene therapy vectors for central nervous system (CNS) diseases and liver-directed therapies.
Symbiosis Pharmaceutical Services reported a successful audit outcome by the UK government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) for its Scottish production site.
