Calidi Biotherapeutics, a clinical-stage biotech developing allogeneic stem cell-based platforms for oncolytic virus immunotherapies, has been awarded a $3.1m grant from the California Institute for Regenerative Medicine (CIRM).
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.
Semarion Ltd, a University of Cambridge spin-out company combining materials engineering and cell biology to tackle unmet drug screening needs, has just closed a £2.14m (US$2.89m) seed funding round.
Biotech EdiGene has announced an R&D collaboration with Haihe Laboratory of Cell Ecosystem to develop hematopoietic stem cell regenerative therapies and platform technology.
CRISPR Therapeutics and ViaCyte, Inc. have received the green light from Health Canada for their Clinical Trial Application for VCTX210: an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D)....
Takeda has received approval from Japan’s ministry of health to manufacture and market its stem cell therapy, Alofisel, for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease (CD).
French innovator, TreeFrog Therapeutics, which is focused on developing affordable stem cell-derived cell therapies, has just closed a US$75m (€64M) Series B financing round, bringing its total funding to date to US$83m (€70M).
Generate Life Sciences is establishing a GMP facility in La Jolla, California that it says will enable end-to-end manufacturing of newborn stem cell biologics, bolstering supply and safeguarding clinical research.
Takara Bio Europe has announced a licensing agreement with Denmark’s PanCryos, a pre-clinical stage biotech company, for its clinical-grade human embryonic stem (hES) cell lines, starting material for cell therapy development.
Fujifilm Irvine Scientific has become the exclusive, worldwide distributor of cellnest, a recombinant peptide attachment substrate that is said to provide optimal adhesion and proliferation of stem cells in chemically defined, animal component-free conditions.
Novo Nordisk will take over the lease of a manufacturing facility in Fremont, California, where the company will make stem cell-based therapies with optionally licensed technology.
Takeda has said it will review the manufacturing of Alofisel (darvadstrocel) if its €520m ($620m) bid for off-the-shelf stem cell developer TiGenix is successful.
Plasticell has teamed with Anthony Nolan to access the latter’s cord-blood bank and boost patient recruitment for its allogeneic haematopoietic stem cell transplantation (HSCT) therapy trials.
CSL opens a $173m albumin plant in Australia, Kiadis leases a facility in The Netherlands, and ADC Bio signs a construction agreement in Wales. Welcome to Biopharma-Reporter’s facility round-up.
GSK will look to optimise its induced pluripotent stem cell (iPSC) differentiation processes through collaboration with high throughput tech firm Plasticell.
Shibuya and Promethera Biosciences are establishing a manufacturing platform for cell-derived liver therapies at the latter’s facility in Gosselies, Belgium.
Spain has licensed TiGenix NV's expanded Madrid plant paving the way for a potential European launch of Cx601, its cell therapy for the Crohn's disease complications.
The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against "unscrupulous" stem cell firms.
Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohn’s disease stem cell therapy licensed from TiGenix.
Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.
GE Healthcare has acquired cryopreservation technology firm Asymptote and says more investments are likely as it builds an “end-to-end ecosystem” for cellular therapy production services.
GE Healthcare has agreed to help Cellular Biomedicine Group (CBMG) develop CAR-T and stem cell production technologies to support its aim of making 10,000 cancer cell therapies a year.
Sumitomo Dainippon Pharma Co Ltd has ordered cell culture technologies from Hitachi as part of its effort to develop a treatment for Parkinson’s disease.
The only practical way to scale-up volumes of mesenchymal stem cells (MSCs) is by using microcarriers in single-use bioreactors, say scientists from A*STAR and Instituto Superior Técnico.
Dispatches from the 1st Stem Cell Community Day, Hamburg
Process automation should be incorporated early when developing large scale cell therapy manufacturing platforms, according to a lead scientist from the UK Catapult.
Plasticell has partnered with Singapore’s Agency for Science, Technology and Research (A*STAR) and the Nanyang Technological University (NTU) to advance its stem cell pipeline.
'One-litre bioreactor scale currently the maximal for stem cell expansion and differentiation'
Stem cell therapy developers are lacking production scale-up technologies, says the chair of an upcoming conference bringing industry and academia together to address the problem.
TiGenix is using Lonza as a US CMO and Takeda as an ex-US commercialization partner to launch and trial its off-the-shelf stem cell therapy for a complication of Crohn’s disease.
Asterias Biotherapeutics has selected Cognate BioServices for the process development and manufacture of its autologous dendritic cell vaccine candidate, AST-VAC1.
StemCells Inc has merged with Israeli medical devices firm Microbot Medical three months after terminating a Phase II trial of its HuCNS-SC human neural stem cells.
A human plasma protein could make producing pluripotent stem cells cheaper and faster according to academics in the UK and Sweden and partner GE Healthcare.
Researchers supported by the National Institutes of Health (NIH) have developed a clinical-grade stem cell line, which will help accelerate early-stage clinical research.
India’s first off-the-shelf cell therapy product, StemCells Inc plummets on Phase II trial termination, and Accellta looks to 3D printing. Welcome to Biopharma-Reporter’s stem cell round-up…
