August 22, 2019, Dresden, Germany — Due to their high accessibility and extensive beneficial properties, human Mesenchymal Stem Cells (hMSC) offer exciting promises in a plethora of applications in regenerative medicine, particularly in cell-based therapies. The major challenge of hMSC-based therapy is the large-scale expansion of cells in order to achieve the cell numbers necessary for therapeutic treatment. [Read more…]
Nucleus Biologics acquires Primorigen Biosciences, gains proprietary, high yield, recombinant protein platform
SAN DIEGO, Aug. 6, 2019 — Nucleus Biologics, a leader in precision cell culture, is pleased to announce the acquisition of Primorigen Biosciences, Inc. The addition of Primorigen’s Vitronectin XF™ and platform recombinant protein production technology will play a huge role in Nucleus’ strategy of offering traceable, reproducible and xeno-free (XF) cell culture ecosystems for the cell and gene therapy space. [Read more…]
GenCure announces breakthrough first run of 80-liter bioreactor
Biomanufacturing CDMO among first to harvest adult stem cells at large scale
SAN ANTONIO, Texas – In a breakthrough for the regenerative medicine industry, GenCure announced today that its biomanufacturing services team has successfully completed production runs expanding and harvesting human mesenchymal stem cells (hMSCs) in an 80-liter bioreactor. GenCure, a subsidiary of BioBridge Global (BBG), announced a major expansion of its biomanufacturing facilities in February of this year. [Read more…]
Biological Industries USA Adds Strategic Offering of Small Molecules to its Stem Cell Portfolio
August 8, 2019 — CROMWELL, Conn. — Biological Industries USA (BI-USA), a division of Biological Industries Beit Haemek Israel (BI), and provider of cell culture tools for translational research, today announced the addition and sale of small molecules for stem cell applications; specifically for enhancing research in diabetes, neural disorders, and cardiovascular disease.
Small molecules can be used to modulate biological signals for a multitude of applications, including cellular reprogramming, stem cell self-renewal, and the differentiation of stem cells into specific lineages, altogether advancing the rapidly evolving field of translational cell therapy. [Read more…]
Orchard Therapeutics Receives RMAT for OTL-103 for Treatment of Wiskott-Aldrich Syndrome
Three-Year Registrational Data Set to be Presented by Year End 2019
Regulatory Submissions Planned in the U.S. and Europe for 2021
BOSTON and LONDON, July 29, 2019 — Orchard Therapeutics (Nasdaq: ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for OTL-103, Orchard’s ex vivo autologous hematopoietic stem cell (HSC)-based gene therapy for the treatment of Wiskott-Aldrich Syndrome (WAS) developed at the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy. [Read more…]
