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FUJIFILM Irvine Scientific Announces Construction of a New Cell Culture Media Manufacturing Site in Europe

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New facility brings rapid, reliable delivery of cell culture media to European customers

FUJIFILM Irvine Scientific - Product Manager Job PostSANTA ANA, California – July 2, 2019: FUJIFILM Irvine Scientific, Inc., a global leader in the innovation, development, and manufacture of cell culture media, announced plans to open a third manufacturing facility located in Tilburg, Netherlands. The company currently has sites in the United States and Japan. Fujifilm’s investment in this project demonstrates its commitment to accelerate development in bioproduction, and cell and gene therapy markets. [Read more…]

CARsgen’s CAR-T Therapy CT053 for R/R Multiple Myeloma is 37th Publicly Announced RMAT

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SHANGHAI, Oct. 28, 2019 — CARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM). [Read more…]

Fate Therapeutics Announces the Opening of its cGMP Manufacturing Facility Dedicated to iPSC-derived Cell Therapies

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State-of-the-Art Facility Designed to use Clonal Master iPSC Lines as Renewable Cell Source for Manufacture of Off-the-Shelf Product Pipeline

Fate Therapeutics - iPSC derived CAR-TSAN 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…]

Positive Study Results of Phase IIa Clinical Trial Using IV Administered MSCs for Ischemic Stroke Published in Peer-Reviewed Stroke Journal

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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…]

PLEXOVAL Exosome Wound Healing Human Study Starts

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  • A world-first study using cell free exosome product manufactured using Exopharm’s LEAP Technology

  • Study sites at the Royal Melbourne Hospital and Australian Red Cross Blood Service

  • Results by mid 2020

26 August 2019, Melbourne, Australia: Regenerative medicine company Exopharm Limited (ASX:EX1) announces the start of the PLEXOVAL Phase 1 study, the first human clinical trial using exosomes for wound healing. [Read more…]

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