This article identifies four key processing technologies that are utilized by cord blood banks worldwide and the companies responsible for developing each one. Automated processing systems have many benefits, including speed, processing efficiency, and cost-savings. However, automated processing systems have not always dominated the cord blood banking industry.
Mesenchymal Stem Cells (MSCs)
Mesenchymal stem cells (MSCs) are a well-characterized population of adult stem cells that can differentiate into a variety of cell types (chondrocytes, osteoblasts, adipocytes, myocytes, and more).
FDA Meeting Provides Clear Path for Cynata US Development Plans
- Cynata Pre-IND meeting with the US FDA completed successfully
- FDA confirms CymerusTM manufacturing dossier meets expectations
- Clear path determined for preclinical and clinical protocol requirements for product development in US
- Potential to take advantage of fast-track provisions under the new 21st Century Cures Act
Melbourne, Australia; 5 July 2017: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), has received written advice from the United States Food and Drug Administration (FDA) regarding the regulatory approval path for Cynata’s proprietary CymerusTM mesenchymal stem cell (MSC) products in the US. This advice follows a pre-Investigational New Drug (pre-IND) meeting (announced 19 April 2017), which Cynata recently held with the FDA’s Office of Cellular, Tissue and Gene Therapies.
The FDA confirmed that the scope and substance of Cynata’s “Chemistry, Manufacturing and Controls” (CMC) dossier is commensurate with its expectations, which indicates that CymerusTM MSC products are expected to be of suitable quality for clinical trial use in the US. [Read more…]
Cynata Therapeutics GvHD Clinical Trial and Corporate Progress
- Patient dosing commenced in world-first Phase I trial of stem cell therapy CYP-001 in graft-versus-host disease; recruiting at six centres in the UK and Australia
- Secured $60-million-plus FUJIFILM partnership and license option for CYP-001 in GvHD
- Raised additional $10 million: $4 million equity investment from FUJIFILM and $6 million placement
- Reported positive pre-clinical data in heart attack and asthma; expanded pre-clinical pipeline to acute respiratory distress syndrome
- Filed two new patent applications with IP Australia to expand opportunities in cancer immunotherapy
- Completed pre-Investigational New Drug meeting with U.S. Food and Drug Administration Office of Cellular, Tissue and Gene Therapy; written recommendation expected by July 2017
Cynata Files New Patent Application for Cymerus™ Stem Cell Technology in Oncology
- Application filed with IP Australia would expand patent estate to immunotherapy
- Creates new opportunities in the growing field of immunotherapy and reinforces a position in oncology
RegMed’s First Xeno-Free Human Mesenchymal Stem Cell (MSC) Cell Banks
RoosterBio has announced the launch of the Regenerative Medicine (RM) industry’s first xeno-free (XF) hMSC cell banks to advance and simplify stem cell biomanufacturing. By incorporating XF starting materials at early stages, RM scientists can perform more clinically relevant work, resulting in an expedited path towards clinical testing programs. Due of the importance of this announcement, I followed up with Dr. Priya Baraniak, Director of BD & Strategic Marketing at RoosterBio, to further explore details of the launch. [Read more…]
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