The first patient has been dosed in the Phase 1/2 clinical trial of OCU400, a modifier gene therapy candidate for the treatment of retinitis pigmentosa (RP) resulting from mutations in the nuclear receptor subfamily 2 group E member 3 (NR2E3) and Rhodopsin...
The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.
While skills shortages present one of the main challenges to the biopharma industry, North Carolina believes its investments in the life science ecosystem have given it a ‘multiple decade jumpstart’ in building a successful biopharma hub for both manufacturing...
Janssen’s Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
Exothera, a CDMO specializing in the industrialization of vaccine and gene therapy processes, reports that it has achieved GMP certification for its facilities in Jumet, Belgium.
The Cell and Gene Therapy Catapult (CGT Catapult) has today published the ‘National Cell and Gene Therapy Vision for the UK’, a document outlining recommendations for a national strategy for the adoption of cell and gene therapies.
Fujifilm Irvine Scientific, Inc, has announced the acquisition of Shenandoah Biotechnology, a company supplying recombinant proteins to the drug discovery, life science research, and cell and gene therapy markets.
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.
A study that reveals new understanding of Chimeric Antigen Receptor (CAR) T cell functionality is said to underscore the critical role that cell avidity or binding plays in uncovering and optimizing CAR T cells.
A California based biotech has tripled its capacity to manufacture GMP grade induced pluripotent stem cells (iPSC) space through the expansion of its contract development and manufacturing (CDMO) facility.
The selected companies, the inaugural cohort for MassBioDrive, get to participate in an eight-week program focused on growing businesses and advancing breakthrough science.
Novartis continues down the third-party manufacturing route, as it secures an agreement with Carisma Therapeutics, a firm developing a cell therapy platform focused on engineered macrophage-based therapeutics.
Charles River recently announced the expansion of its plasmid DNA and viral vector development and manufacturing capabilities in Europe; it says the move is to support the growing need of customers and to safeguard future supply.
Lipid nanoparticle systems (LNPs) as a delivery mechanism for novel drug modalities are proving effective, but there are bioanalytical challenges associated with encapsulation, says an expert.
AskBio, a gene therapy company owned and operated as a subsidiary of Bayer AG, and Touchlight, a biotech focused on enzymatic DNA production, have announced a revised structure to their former joint venture, Touchlight AAV.
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.
Mission Bio says it is paving the way for the routine use of its technology in clinical trials on materials to support the next wave of life-saving CGT treatments.
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.
AES Clean Technology, a supplier of cleanroom facilities for the pharmaceutical and biopharmaceutical sectors, is ploughing $14.2m into a new US manufacturing facility.
Kyverna Therapeutics, a cell therapy company engineering a new class of therapies for autoimmune diseases, has closed an oversubscribed $85m Series B financing round led by Northpond Ventures.
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.
Ori Biotech Ltd, an innovator in the cell and gene therapy (CGT) manufacturing sphere, has secured over US$100m in an oversubscribed Series B funding round.
Performance Cell Manufacturing, a CDMO with a focus on manufacturing cell therapies, has been acquired by Great Point Partners and will now operate under the name Cellipont Bioservices.
Samsung Biologics flags further facility construction plans, with biologics, cell and gene therapies and next-generation vaccines to be the focus of those new sites.
Protagen, BioAnalytix, and GeneWerk this week announced their unified operations and re-brand as ProtaGene, a CRO partner for the biologics and cell and gene therapy developers, from discovery to commercialization.
Healthcare investors, GHO Capital Partners LLP, have invested in Scotland based, RoslinCT, a contract development and manufacturing organization (CDMO) focused on advanced cell therapies.
ATMPS Ltd, a UK developer of blockchain-based cell orchestration platforms for advanced therapies is collaborating with US quality and compliance consultancy, Assurea LLC, to develop a fully complaint blockchain approach for end-to-end supply chain management...
Indian multinational, Piramal Pharma Limited (PPL), has taken a minority stake in Yapan Bio, a CDMO, based in Hyderabad, with expertise in biologics and vaccines.
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.
Novartis has introduced its T-Charge platform at ASH 2021, which it says will serve as the foundation for various new investigational CAR-T cell therapies in its pipeline.
This month saw BioCina officially open its new biologics manufacturing facility in Adelaide, Australia, flagging it as the only TGA, EMA, Health Canada and US-FDA approved commercial facility of its kind in the country.
Taiwan based contract manufacturer, Bora Pharmaceuticals, in partnership with Taishin Healthcare Limited, is ready to spend millions to expand its footprint in the CDMO sector.
Catalent is reporting that the technology transfer for the manufacture of BrainStorm Cell Therapeutics’ autologous cellular therapy at its facility in Houston, Texas has been finalized.
Fujifilm Irvine Scientific, Inc, is to build a new bioprocessing center in China, with the goal of ensuring local cell culture media optimization support for vaccines, advanced therapies, and biotherapeutic drug development.
Trince, a spin-off of Ghent University (UGent) that is focused on advancing cell-based science and therapeutics by facilitating the delivery of molecules into cells, both in vitro and ex vivo, has raised €4m (US$4.5m) from investors.
Genezen, a cell and gene therapy focused CDMO, has just opened a new process development and analytical lab, a build that represents the first phase of a 75,000+ square foot cGMP-compliant lentiviral and retroviral vector production facility in Indianapolis.
Several contract development and manufacturing organization (CDMO) supported biopharma projects have been flagged in the past month. We take a closer look.
The EMA has validated Atara Biotherapeutics' Marketing Authorization Application (MAA) for tabelecleucel (tab-cel), the first time an off-the-shelf allogeneic T-cell therapy will be evaluated by any regulatory agency in the world.
A new report reveals that “speed-to-market” has jumped up from a lower-ranking business driver before the pandemic to the top priority today for biopharma companies, overtaking cost-based considerations by a healthy margin.
Ncardia, a human-induced pluripotent stem cell-based (iPSC) technology company, has secured more than US$60m in capital through a strategic partnership with Kiniciti, a US based investor with a focus on the global cell and gene therapy ecosystem.
Korean company, SK, is investing in the Philadelphia-based Center for Breakthrough Medicines (CBM), a move that will support the US company in its bid to become the world's largest end-to-end cell and gene therapy contract development and manufacturing...
