CDMO Matica Bio has opened a new 45,000-square-foot facility dedicated to the production of viral vectors and cell-based products used in cell and gene therapies, vaccines, oncolytic therapies and other genetic medicines.
The US Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’ Durham, N.C. site, a multi-product gene therapy manufacturing facility, which will start producing Zolgensma immediately.
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...
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.
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.
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.
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.
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.
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.
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.
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...
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.
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.