NIH Clinical Center Confirms Quality of Clinical-Grade Cells Produced by the Quantum® Cell Expansion System
CaridianBCT, the leading global provider of technology, products and services in the blood banking, transfusion medicine and cell therapy industries, announced today that the National Institutes of Health (NIH) Clinical Center has verified the consistent cell yields and cell quality produced by a prototype of the Quantum Cell Expansion System, commending the system´s ability to reproducibly expand clinical doses of bone marrow stromal cells (BMSC), also known as mesenchymal stem cells. With these findings, the agency recently purchased the commercially available system for use in future clinical applications.
As a novel, automated system for growing adherent and suspension cells in a functionally closed environment, using hollow-fiber bioreactor technology, the Quantum system´s unique controls streamline cell culture, deliver reproducible processes and reduce the risk of contamination for large-scale clinical cell manufacturing.
The NIH Bone Marrow Stromal Cell Transplantation Center, operating in the Department of Transfusion Medicine, completed its evaluation of the system in August, concluding that the technology successfully reproduced large quantities of adult bone marrow stromal cells in an automated, functionally closed environment with a final cell product biologically equivalent to the cell quality found with traditional flask or cell factory methods. NIH presented these data at the 2010 meeting of the International Society for Stem Cell Research.* The organization hopes to submit the BMSC manufacturing process utilizing the Quantum system to the Food and Drug Administration to meet the product scale-up needs for the treatment of a range of conditions.
"NIH indicated that they were pleased with the results of the Quantum system in creating clinical-grade stromal cells using Good Manufacturing Process (GMP) methods," said CaridianBCT´s Kim Nguyen, Ph.D., senior product specialist for the Quantum system. "This bench-top, automated device enables the high throughput, reproducibility and quality the industry needs to meet the cellular product manufacturing requirements of Phase I, II and III clinical trial needs."
Investigators from the Trans-NIH Bone Marrow Stromal Cell Transplantation Center co-coordinated by Dr. Harvey Klein, chief of the Department of Transfusion Medicine at the Clinical Center, and Dr. Pamela Robey of the National Institute of Dental and Craniofacial Research, have worked with a prototype of the Quantum system since 2009. The collaboration with CaridianBCT began in an effort to find ways to reduce the opportunities for contamination found in manual cell manufacturing methods, free staff time for other procedures, streamline the cellular manufacturing workflow, and identify more effective ways to efficiently produce cellular products to treat human diseases and disorders with new cutting-edge therapies.
"CaridianBCT is proud to collaborate with the NIH to further the development of cell therapies with the Quantum system, particularly in the growth of bone marrow stromal cells for potential treatment of autoimmune disorders, acute host-versus-graft disease and various heart indications," said Tom Jordan, Executive Vice President, Global Commercial Operations. "We consider NIH a valued partner in the effort to improve lives through innovation, quality and services."
About CaridianBCT:
The world´s leading supplier of products and services in the blood banking, hospital and biotech industries, CaridianBCT serves customers with products that provide patients with the lifesaving gift of blood. Following the April 2011 Terumo Corporation acquisition, CaridianBCT and Terumo Transfusion will combine as the global leader in blood component technology. The combined entities remain dedicated to improving lives through products and services designed to meet the ever-expanding demand for safe, high-quality blood components. Headquartered in Lakewood, CO, the company has global operations in 32 countries and employs approximately 2,500 people. For more information, visit www.caridianbct.com.
About Terumo Corporation:
Tokyo-based Terumo Corporation is one of the world´s leading medical device manufacturers with $4 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation´s shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan´s leading stock index.
Notes:
*Data on file
No endorsement of any organization, product or service mentioned here is intended by the National Institutes of Health or its employees, nor should it be inferred.