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Highlights:
SAN DIEGO, Sept. 30, 2019 — Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the Company has opened its current Good Manufacturing Process (cGMP) compliant manufacturing facility for the clinical production of its off-the-shelf natural killer (NK) cell and chimeric antigen receptor (CAR) T-cell product candidates. [Read more…]
SAN DIEGO, Calif. – September 30, 2019 – Results from a study sponsored by Stemedica Cell Technologies, Inc., a global biotechnology company that uses allogeneic stem cells for ischemic conditions, form the basis for a peer-reviewed paper published in Stroke entitled “Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke.” Co-authors include Michael L. Levy, MD, PhD, John R. Crawford, MD, Nabil Dib, MD, Lev Verkh, PhD, Nikolai Tankovich, MD, PhD and Steven C. Cramer, MD. [Read more…]
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…]
On September 4, 2019, Magenta Therapeutics announced it had received an FDA Regenerative Medicine Advance Therapy (RMAT) designation for MGTA-456, an expanded CD34+ cell therapy treatment used in place of single umbilical cord blood (UCB) transplantation. This one-time stem cell treatment is being investigated for the treatment of multiple inherited metabolic disorders. While there are 36 publicly announced RMAT designations, the FDA states that 40 or more have been awarded to date. [Read more…]
