Induced pluripotent stem cells (iPSCs) are promising starting materials for several clinical and industrial applications in cell therapy production, drug discovery, and in vitro screening. But as I learned from Maxime Feyeux (cofounder and chief science officer of TreeFrog Therapeutics in Bordeaux, France), such cells are a relatively new option in the toolbox of cell therapy developers. Advanced-therapy products can require controlled proliferation and differentiation of millions or even billions of iPSCs depending on the clinical indication, he pointed out,…
Search Results for: regenerative medicine
Quality cell banks de-risk regenerative medicine development, says consultant
Minimizing variability in cells used to make regenerative medicines is vital but challenging according to an expert, who says a quality cell bank is key. Cell and gene therapies have the potential to revolutionize medicine and allow physicians cure previously untreatable diseases. But developing a process that produces a stable, consistent product is a technical challenge. A major challenge is that the starting materials – the cells from which the medicines are produced – need to be carefully handled says…
Cost of Goods Is Crucial for the Future of Regenerative Medicine: CAR-T Cell Therapy Provides a Case Study in Perspective
In the history of regenerative medicine, 2017 was a critical year. With approvals for Kymriah (tisagenlecleucel) from Novartis AG, Yescarta (axicabtagene ciloleucel) from Kite Pharma (a Gilead company), and Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics, cell and gene therapies finally made their mark on the regulatory landscape. Then in 2018, those products began both treating patients and bringing in revenues for their sponsor companies. “Patients are being treated, and biotechnology and pharmaceutical companies are being paid for treating them,†said…
Second Sartorius Research Xchange Forum Focuses on Regenerative Medicine and Cell Therapy
Promoting interdisciplinary exchange between science and industry on the topics of regenerative medicine and cell therapy: this is the objective Sartorius will be pursuing by hosting its second Research Xchange Forum on March 20 and 21, 2018, at Sartorius College in Goettingen. Experts from the biotechnology sector will report on the new developments in cell therapy. Sartorius has gained guest speakers Dr. Priscilla N. Kelly, editor of the journal Science, and Dr. Stefan W. Hell, the winner of the Nobel…
Growth Projections for the Regenerative Medicine Market
One of the fastest growing medical markets with great potential, regenerative medicine treats chronic diseases that were once untreatable. Therapy using live cells is increasingly used to replace damaged tissue, deliver gene therapies to target tissues and organs, and stimulate self-healing along with a number of other applications. View the full article below – Login Required Reference 1 Regenerative Medicines Market: Global Opportunity Analysis and Industry Forecast, 2015–2022. Allied Market Research: Pune,Maharashtra, India: August 2016; www.alliedmarketresearch.com/regenerative-medicines-market. 2 Chartrain NA, Williams…
Collaboration Will Drive Regenerative Medicine: Toronto Development Center Will Help to Advance the Field
With support from the federal government of Canada, GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) are pushing into new frontiers to advance the progress of cell therapy and regenerative medicine. When I first met Michael May, president and chief executive officer (CEO) of CCRM, both our organizations had been exploring opportunities in parallel to drive the cell therapy industry forward. CCRM’s mission is to create and sustain a global nexus for company creation, technology and cell…
Manufacturing Strategies for Regenerative Medicine Success
Just a few years ago, my requests for manuscripts detailing logistical considerations for cell-therapy manufacturing were met with puzzlement. The assumption seemed to be that such processes already existed for commercial biopharmaceuticals and would simply be adapted later. In quite a few cases, adopting a commercial mind-set did not appear to be a goal at all, with hands-on practitioners used to applying procedures in hospital settings. For those of us who remember early discussions about commercialization and cost-containment for protein…
Planning for Commercial Scale of Cell Therapy and Regenerative Medicine Products, Part 2: Clinical Efficacy, Reimbursement, and Needle-to-Needle Logistics
Cell therapy is an emerging pillar in healthcare with the potential to provide curative solutions to a wide range of indications. The biological complexities through which cell technologies exert their clinical impact (especially those used in immunotherapies for cancer) provide opportunities for novel modes of immune regulation, cell targeting, and payload delivery. Cells also can serve as vehicles for genetic content, which the gene therapy industry is now investigating. Since early 2004, Invetech has worked with organizations dedicated to cell…
Planning for Commercial Scale of Cell Therapy and Regenerative Medicine Products, Part 1: Achieving Manufacturability and Managing Cost of Goods
Much mystique and mystery surround the emerging industries of cell therapy and regenerative medicine. As companies progress toward commercial manufacture with potential game changers (e.g., cures for cancer and diabetes) the industry could be on the verge of significant breakthroughs. However, with no real successes to date, the question is raised: What core attributes are required to achieve commercial success? The tale of Dendreon’s struggles highlights how difficult it can be to commercialize even an approved cell therapy product. Since…
World Stem Cells Regenerative Medicine Congress
Why you should attend The main focus is on: Finance & Investment: Access investment advice and partnership opportunities through the Investor Forum Scalable Manufacturing: Identify best practices in technology and latest updates from biotechs, through interactive roundtables Translational Medicine: Discover how best to gain market access for cell therapies Tissue Engineering: Hear pioneering innovations in tissue engineering as well as organ regeneration and 3D bioprinting Commercialisation: Understand how industry leaders view the clinical and commercial futures of stem cells and…