Palo Alto, California, May 25, 2021 – I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-winning technology “induced pluripotent stem cells (iPSCs)” received a third-party certification as US FDA cGMP compliant for its manufacturing facility “Peace Engine Kyoto,” in Kyoto Japan. Peace Engine Kyoto is owned and managed by its sole subsidiary I Peace, Co. Ltd. The facility was awarded a permit in 2020 by Japan’s Ministry of Health, Labour, and Welfare to manufacture specific cell-based products. [Read more…]
FDA Regulation of Cellular and Tissue-Based Products with Dr. Riam Shammaa
In this interview with Dr. Riam Shammaa, Medical Director at the Canadian Centres for Regenerative Therapy (CCRT), we discuss FDA regulation of human cells, tissues, and cellular and tissue-based products (HCT/P’s), as well as the difference between 351 and 361 products.
While the FDA has a critical role in market oversight, individual market participants are also responsible for understanding the regulatory framework affecting the sale, distribution, and utilization of cell therapy, gene therapy, and tissue engineering products. This interview is aimed to help you understand the FDA framework affecting HCT/Ps within the U.S, as well as the framework and recommendations implemented by Health Canada.
RoosterBio Releases RoosterGEM™, Cell and Gene Therapy’s First Complete Transduction Medium
RoosterGEM™, a complete genetic engineering medium, empowers product developers to realize up to four-fold increased transduction efficiency in primary cells, and achieve a greater than 50% reduction in overall gene transfer cost.
Frederick, MD, May 20, 2021 – RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks and hMSC bioprocess systems for cell and gene therapy product developers, today announced the launch of its product RoosterGEM™, a stand-alone, complete gene transfer medium that is optimized to remove key challenges in primary cell genetic modification. [Read more…]
C-Stem™ outperforms 2D & aggregate cultures in benchmark of cell culture technologies for the mass-production of human induced pluripotent stem cells
TreeFrog Therapeutics presents new data at the 24th Annual Meeting of the American Society for Cell & Gene Therapy.
Bordeaux, France, May 11, 2021 – One month after announcing unprecedented exponential amplification of human pluripotent stem cells (hiPSCs) in a 10L bioreactor French cell therapy company, TreeFrog Therapeutics, released previously unpublished data at the 24th Annual Meeting of the American Society for Cell & Gene Therapy. The findings compare the continuous expansion over 28 days of human induced pluripotent stem cells (hiPSCs) in 2D cell culture, aggregate culture in bioreactor, and bioreactor-based C-StemTM technology. The benchmark demonstrates that C-StemTM outperforms both the 2D and aggregate cell cultures, with a cumulated amplification of over 151 millionfold over 28 days, achieved in only four passages. [Read more…]
Landmark MSC Trial for Parkinson’s Disease Authorized by U.S. FDA
April 28, 2021, SUGAR LAND, Texas — Houston-area non-profit Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received FDA authorization for a Phase II double-blind placebo controlled clinical trial to assess the efficacy and safety of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells to improve activities of daily living and quality of life in subjects with Parkinson’s Disease.
The trial is the first globally to administer pure adipose-derived mesenchymal stem cells to Parkinson’s patients in such high quantities over repeat treatments. Twenty-four patients will be randomized to receive six intravenous infusions of 200 million stem cells each. [Read more…]
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