A new state-of-the-art facility dedicated to plasmid manufacturing is now operational in Gerenzano, Italy. The new site will couple with the existing GMP facility active in the Cell and Gene (C&G) therapy space. With 800m2 (8,000 square feet) of cleanrooms, the two facilities of Anemocyte, the first Biotech Manufacturing Organisation (BMO), will address manufacturing needs of Somatic Cells, Non-Viral Modified Cells, Vesicles and Plasmids for Viral Vectors. [Read more…]
First iPSC-Derived CAR-T Therapy by CiRA and Takeda Nears Clinical Testing
− iCART Program Advances the Potential for a Highly Scalable, Lower Cost, Off-the-Shelf CAR T-Cell Therapy to Treat Cancer
KYOTO and OSAKA, Japan I July 16,2019 – The Center for iPS Cell Research and Application (CiRA) at Kyoto University and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that a novel induced pluripotent stem (iPS) cell-derived chimeric antigen receptor (CAR) T-cell therapy (iCART) has been transferred from their T-CiRA research collaboration to Takeda as the program begins process development toward clinical testing. Under the terms of the T-CiRA agreement, Takeda has the global rights to develop and commercialize the iCART product and CiRA will receive development and approval milestones. The teams will continue to collaborate as they prepare the iCART program for a clinical trial in 2021. [Read more…]
U.S. FDA Approved RMATs on the Rise
With recent news from Sangamo Therapeutics and Krystal Biotech, the count of announced RMAT (“Regenerative Medicine Advanced Therapy”) designations has risen to 30.
Krystal Biotech received an RMAT designation for its gene therapy KB103 on June 24, 2019. KB103 is being studied for its wound closure capacity in patients with severe generalized recessive dystrophic epidermolysis bullosa (“RDEB”). The FDA also granted a RMAT designation for Sangamo Therapeutics’ SB-525, an investigational gene therapy being developed in collaboration with Pfizer to treat severe hemophilia A. SB-525 is the first hemophilia A gene therapy to receive RMAT designation. [Read more…]
ElevateBio to Operate at a Hybrid CDMO and Investment Holding Group
ElevateBio, a newcomer to the cell and gene therapy sector, is taking a different approach than the competition. Founded only months ago in early 2019, the company plans to aggregate a portfolio of cell and gene therapy companies that will develop, manufacture and commercialize life-transforming medicines.
It has launched with an unusual business model, which is to be a hybrid CDMO for cell and gene therapy companies, as well as an investment holding company. It will accomplish this feat by offering “R&D and cGMP manufacturing facilities to be shared across several portfolio companies, each with a different disease focus.”
Key to ElevateBio’s plan is the construction of an R&D and cGMP manufacturing facility in Cambridge, MA, that it calls BaseCamp. The complex will act as a centralized research and manufacturing group to support a portfolio of promising cell and gene therapy companies, each which will have a different disease focus.
ExCellThera enters into a manufacturing and collaboration agreement with New York Blood Center
MONTREAL, MAY 7, 2019 – ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today that it has entered into a manufacturing and collaboration agreement with Comprehensive Cell Solutions (CCS), a division of New York Blood Center (NYBC) for the clinical grade production of ExCellThera’s lead cell therapy product, ECT-001. [Read more…]
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