Project to evaluate system's capability and scalability in manufacturing allogeneic cell therapies for clinical use
LAKEWOOD, Colo., USA— August 7, 2014—Terumo BCT's Quantum® Cell Expansion System is now under evaluation by Athersys, Inc., a biopharmaceutical company dedicated to the research and development of stem cell therapies, as a manufacturing platform for Athersys' allogeneic multipotent adult progenitor cell (MAPC®) products. ReGenesys BVBA, Athersys' affiliate in Belgium, will manage the evaluation.
The Quantum system is a closed cell culture and expansion system enabling effective control and assessment of important operating parameters. ReGenesys will evaluate the potential for scaling the cell culture process by using multiple units to meet its manufacturing requirements and will further quantify advantages over standard cell manufacturing approaches.
Key Facts about the Evaluation:
MAPC therapies, such as Athersys' cell therapy candidate MultiStem®, are intended for allogeneic use and large scale production, meaning that materials from a single donor could be used to produce a large number of doses for eventual clinical use
The project, which is expected to be completed in early 2015, aims to demonstrate the feasibility of using the Quantum system to produce clinical-grade MAPC therapies at scale
ReGenesys will assess certain operating parameters and cell performance, along with unit-to-unit consistency and reproducibility across production runs
Key Facts about the Quantum System:
The Quantum system is functionally closed, hollow-fiber bioreactor technology that streamlines the cell culture process
Through its fully automated processes, the Quantum system has been shown to reduce labor by up to 80 percent over manual cell culture processes
The Quantum system is customizable and can be adapted to meet production needs
The Quantum system offers a small, space-saving footprint, increases throughput in existing space and can reduce the need to build additional dedicated current Good Manufacturing Practice (cGMP) facilities
Dave Flaten, Vice President, Cell Processing, Terumo BCT
"Athersys is known in the cell therapy field as a top innovator. We are excited about working with them for this study using the Quantum system for clinical production of MAPC cells intended for allogeneic therapy, and providing Athersys with all of the workflow and automation benefits and competitive advantages our Quantum system offers."
William (BJ) Lehmann, Jr. , President and Chief Operating Officer, Athersys
"We have worked extensively with the Quantum system as part of our cell therapy research activities. We are very excited to further assess its potential for our clinical use through an evaluation in a clinical scale manufacturing system. Based on our previous work, we expect that the project will confirm the feasibility and merits for integrating the Quantum system into our ongoing clinical manufacturing activities."
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. 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 therapeutic product candidates designed to extend and enhance the quality of human life. The company is developing its MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The company currently has several clinical stage programs involving MultiStem cells, including treatment of inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft-versus-host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products.
Global Corporate Communications