Emmes has announced the creation of a dedicated center for cell and gene therapy research: which will focus on supporting clinical trials for the Clinical Research Organization’s (CRO) clients.
The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.
The US Food and Drug Administration (FDA) has approved Kite’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production.
A push toward multimodal businesses is encouraging greater reliance on contract development and manufacturing organizations (CDMOs), finds a new report.
Ncardia’s cell therapy development and manufacturing business Cellistic will acquire Celyad Oncology’s GMP grade cell therapy manufacturing capability, covering Celyad’s Mont-Saint-Guibert facility in Belgium and all related staff.
AGC Biologics and RoosterBio have launched a strategic partnership to create an end-to-end solution for the development and production of hMSC and exosome therapeutics.
The European Commission (EC) has approved Kite’s CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
Sernova and Evotec are teaming up on an implantable beta cell replacement therapy to replace insulin injections for the millions of patients with diabetes.
AGC Biologics will add viral vector suspension technology and capacity for the development and manufacturing of gene therapies at its commercial-grade campus in Longmont, Colorado.
Regenxbio says it is to delay dosing of patients in its DMD gene therapy clinical trial following a quality issue at an unnamed third-party contract manufacturer.
Cytiva is opening a new 7,400m² manufacturing facility in Grens, Switzerland this month: which will serve as a center of excellence for the company’s cell and gene therapy business as well as a being a base for European customer training programs.
Lonza has added new integrated capabilities in cell binding, cell separation, and bead removal to its closed, automated, and scalable platform for personalized therapy manufacturing.
Cryoport, Inc. has entered into a partnership with specialized Belgian CDMO, Cell Matters, to deliver end-to-end cryopreservation services for leukapheresis derived therapies supporting both autologous and allogeneic cell therapies.
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.
Automated cell therapy manufacturing processes could reduce manual intervention and human errors, enabling more robust processes, improved product quality, and lower costs.
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.
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.
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.
Sphere Fluidics, a UK company that has developed and is commercializing single cell analysis systems underpinned by its picodroplet technology, has just closed a US$40m investment round.
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.
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
Special Edition: Reviewing the advanced therapy pipeline
As a relatively new player in the field of cell therapy, Santen Pharmaceutical has outlined how it is looking to collaborate with key stakeholders in order to shape relevant policies, forge meaningful partnerships and create an optimal environment for...
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.
Cell therapy player, Bone Therapeutics, has secured up to €16m (US$18.9m) in a financing loan from the European Investment Bank (EIB) to accelerate ongoing clinical and commercial development of innovative orthopedic treatments.
Thermo Fisher Scientific Inc and the University of California, San Francisco (UCSF) have formed a alliance to accelerate the development and manufacturing of cell-based therapies.
Bristol Myers Squibb (BMS) will build a new cell therapy manufacturing site in Leiden, the Netherlands: marking the company’s first cell therapy manufacturing facility in Europe and its fifth globally.
TCR2 Therapeutics Inc, a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, has signed a lease for an 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland: which is...
From operational uncertainty and outdated manual processes to new cell lines and a potential shift towards allogeneic cell therapy, CRB’s new report - Horizons: Cell and Gene Therapy - finds the biopharma industry at the critical intersection of obstacle...
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.
