An evaluation in producing MAPCs® showed 40 percent cost savings combined with meeting cell quality needs
LAKEWOOD, Colo., USA—9 October 2015—Athersys, Inc., a biopharmaceutical company, evaluated the use of the Quantum® Cell Expansion System from Terumo BCT as a manufacturing platform for producing Multipotent Adult Progenitor Cells® (MAPCs), an adherent stem cell product. The combined yield of 10 Quantum systems consistently delivered batches of more than 9 billion cells that met all safety and quality criteria established for the study. Additionally, results demonstrated a 40-percent cost savings relative to Athersys' current process.
The evaluation took place at MaSTherCell, a contract development and manufacturing organization specializing in the industrialization of cell therapy products. Although MaSTherCell had no prior experience producing MAPCs or using the Quantum system, collaboration with Terumo BCT resulted in technical transfer, process optimization and successful commercial-scale manufacturing within 16 weeks.
The success of the evaluation provided Athersys data for a template for scaling the process using 10 Quantum systems beyond batches of 10 billion cells, if clinical and commercial manufacturing demands arise.
Commercially relevant batch sizes of more than 9 billion cells
Successful adherence to all safety and quality criteria established for the study
40-percent reduction in cost of goods sold (COGS)
KEY FACTS ABOUT THE QUANTUM SYSTEM:
The Quantum system is a functionally closed system, which facilitates compliance with current good manufacturing practices
The Quantum system uses hollow-fiber bioreactor technology within a small space footprint, which can reduce facility size requirements compared to manual cell culture processes
The Quantum system is automated to streamline the cell culture process
The Quantum system is customizable to meet production needs
A Terumo BCT press release covering the beginning of the evaluation
Dave Flaten, Vice President of Cell Processing, Terumo BCT "We are proud of our collaboration with Athersys and what we have been able to accomplish through automation benefits of the Quantum system. Cell manufacturing is an important step in providing stem cell therapies, and the evaluation using our technology provides a template to scale cell manufacturing and better serve patients."
William (BJ) Lehman, Jr., President and CEO, Athersys "We've used the Quantum system in past cell therapy research activities, and the results of the MAPC commercialization evaluation show that the system has capabilities we need to innovate clinical-scale manufacturing. This evaluation was an important step for our stem cell therapy practices and our collaboration with Terumo BCT."
About Terumo BCT
Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
Athersys is a clinical-stage biotechnology company engaged in the discovery and development of therapies designed to extend and enhance the quality of human life. The company currently has several clinical-stage programs involving allogeneic cells for treating multiple disease conditions in the areas of cardiovascular, neurological, inflammatory and immune disease. One key advantage of allogeneic cells is that they can enable off-the-shelf use.
Sherri Hughes-Smith, Terumo BCT Global Integrated Communications
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