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Principal investigator Dr. Jaime Guevara Aguirre, world-renowned expert on growth hormone to conduct the trial of Altsulin® (Microencapsulated Sertoli Cells) in Laron Syndrome Patients
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Laron Syndrome (aka Laron-type dwarfism) is a rare pediatric orphan disease eligible for the FDA “Golden Ticket”
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Phase IIa proof-of-concept trial paves the way to commercial development of Sertoli Cells for the treatment of Type I Diabetes
Synthego Launches High-Throughput Induced Pluripotent Stem Cell Genome Engineering
National Institutes of Health awards contract for CRISPR-based disease modeling in iPS cell lines associated with Alzheimer’s, Stem cell pioneer Bill Skarnes joins advisory board
REDWOOD CITY, Calif., Oct. 22, 2019 — Synthego, the leading genome engineering company, announced the launch of genome engineering for induced pluripotent stem (iPS) cells. The new offering expands Synthego’s automated cell editing to achieve unprecedented editing efficiency of iPS cells at an industrial scale. [Read more…]
FUJIFILM Irvine Scientific Announces Construction of a New Cell Culture Media Manufacturing Site in Europe
New facility brings rapid, reliable delivery of cell culture media to European customers
SANTA 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
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
State-of-the-Art Facility Designed to use Clonal Master iPSC Lines as Renewable Cell Source for Manufacture of Off-the-Shelf Product Pipeline
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…]
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