ARCADIA, Calif., May 7, 2024 — Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell- and tissue-based therapies, has announced a partnership with Pluristyx, Inc., an early stage, privately held biotechnology company specializing in induced Pluripotent Stem Cell (iPSC) products. Combined, this partnership will allow the companies to provide a seamless, end-to-end pathway to therapeutics developers from iPSC derivation to commercial production of iPSC-derived drug products. [Read more…]
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REPROCELL USA Inaugurates GMP Manufacturing Facility for hiPSCs and hMSCs Suitable for Therapeutic Use
REPROCELL to offer a Master Cell Bank (MCB) manufacturing service for the generation of Human Induced Pluripotent Cells (hiPSCs) and Human Mesenchymal Stem Cells (hMSCs) for human therapeutic applications.
BELTSVILLE, Md., May 29, 2024 — REPROCELL has been producing clinically relevant human induced pluripotent stem cells (hiPSCs) by controlling the process of donor recruitment to seed stock hiPSC and encompassing donor eligibility with different geographical regulatory agencies. Raw materials undergo strict selection and a proprietary method of footprint-free RNA reprogramming is used. [Read more…]
Behind the Scenes at Cynata Therapeutics with Dr. Ross Macdonald
Cynata Therapeutics Ltd (ASX: CYP) is a clinical stage regenerative medicine company specializing in stem cell therapeutics that has a proprietary technology for manufacturing induced pluripotent stem cell (iPSC) derived mesenchymal stem cells (MSCs).
I had the honor of interviewing Dr Ross Macdonald, CEO of Cynata Therapeutics. In this interview, we discuss Cynata’s technology platform, the company’s world first achievements, and its clinical trial underway for GvHD. We also explore the company’s strategic goals and the importance of its partnership with Fujifilm in Japan. [Read more…]
Biotherapies Pavilion Back by Popular Demand at 2024 AABB Annual Meeting in Houston, Texas
June 1, 2024, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to announce the return of the Biotherapies Pavilion at the 2024 AABB Annual Meeting, which will take place Oct. 19-22 in Houston, Texas. AABB introduced the inaugural Biotherapies Pavilion in 2023 as a specially designed networking space in the Exhibit Hall, providing biotherapies companies with new and curated opportunities to network with key audiences in the field and gain access to all that the AABB Annual Meeting has to offer including: [Read more…]
C3i Center Inc is First CDMO in Canada to Receive Approval for a Drug Establishment License to Commercially Produce Cell Therapy Drug Products.
Company awarded commercial Drug Establishment License (DEL) for Canada following successful inspection of C3i’s contract development and manufacturing organization (CDMO) facility.
Montreal, Quebec (Canada), June. 19, 2024 — C3i Center Inc (C3i) announced it has received regulatory approval, in the form of a Drug Establishment License (DEL), to commercially produce cell therapies, making C3i the first CDMO in Canada to achieve this milestone.
The approval follows an inspection by the cell and gene therapy experts from Health Canada. The DEL approval recognizes C3i as having industry-leading expertise, regulatory know-how, and strong quality standards. [Read more…]
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