The supply of critical raw materials for cell therapy manufacturing must fulfill the need for cost-effective, safe and functional products that provide reliable and reproducible performance. In case of cytokines, these products are proteins that must fulfill the need for stability, functionality and be contamination-free. Within stability and functionality, considerations of three-dimensional structure and affect
Mycoplasma contamination of cell cultures is an alarming reality: 25% of all cultures are reported to be contaminated with Mycoplasma, and further challenges – such as the fact Mycoplasma is hard to detect with regular light microscopes – make these numbers even more urgent. Mycoplasmas are very small prokaryotes which lack a cell wall. The best option for mycoplasma-infected cell
A commercial and scientific first, and a breakthrough for the emerging field of CAR-T therapy, occurred this week with a pivotal regulatory win for cell therapy. On June 12, 2017, the FDA unanimously recommended for approval Novartis’ CAR-T therapy for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL),
One of the structurally more attractive features of nanofiber scaffolds is their three-dimensional architecture. Because they are thought to more closely mimic the size and environment of the natural extracellular matrix in the body, they continue to be studied not only as cell support scaffolds, but, a new study has shown, robust drug and gene delivery vehicles. Moreover,
On June 26, 2017, the Forum of Regenerative Medicine at the National Academy of Sciences hosted its second public workshop, titled “Navigating the Manufacturing Process and Assuring the Quality of Regenerative Medicine Therapies.” The even brought together over 100 delegates from industry, academia and government alongside regulators, patients and clinicians to discuss the industry’s gaps,
The Forum on Regenerative Medicine at the National Academies of Science, Engineering and Medicine released today a perspective discussion paper on cell therapy manufacturing. The discussion paper, titled “Manufacturing Cell Therapies: The Paradigm Shift in Health Care of This Century,” can be accessed through the National Academy of Medicine perspectives page. It discusses challenges, issues
On Saturday, June 17th, the International Society for Stem Cell Research concluded its 15th Annual Meeting. Taking place at the Boston Convention and Exhibition Center in Boston, MA, the meeting saw over 4,000 delegates – scientists, researchers, academics, industry and regulatory professionals – connect for over 4 days of networking, workshops, talks and scientific and
The 15th International Society for Stem Cell Research (ISSCR) Annual Meeting will be held from 14-17 June at the Boston Convention and Exhibition Center in Boston, MA. Akron will join over 4,000 stem cell scientists, clinicians, and industry professionals from over 50 countries to discuss the latest developments in the field of cell therapy and regenerative medicine. Akron
Myoblasts, from which myocytes are derived, regularly undergo fusion – a process essential for muscle formation during development and regeneration. The process has been extensively studied, though while much is known about it, a protein called myomaker (Tmem8c) is the only muscle-specific protein that is described as being absolutely required for this process. Expression of myomaker in
Dr. Claudia Zylberberg (Akron) will co-chair an upcoming workshop hosted by the Regenerative Medicine Forum at the National Academies of Science, Engineering and Medicine focused on manufacturing and quality aspects in cell therapies. Set to take place on June 26, 2017 in Washington, DC, the workshop will be a public event that will address and discuss challenges
