Improving multicellular therapy through advanced manufacturing
Aastrom’s patient-specific, expanded multicellular therapy, ixmyelocel-T, is based on the company’s proprietary, automated cell-processing system. Our manufacturing process is conducted in a highly-automated, fully-closed and rigorously controlled system. The Aastrom system is scalable and reproducible and located in a 5,000-square-foot centralized manufacturing facility in Ann Arbor, Michigan. Production is done under current Good Manufacturing Practices (cGMP) guidelines required by the US Food and Drug Administration (FDA) with current annual capacity to treat up to 3,000 patients.
Aastrom is developing commercial-scale manufacturing capabilities which will include a pilot manufacturing facility and a commercial-scale, high-throughput facility capable of supporting the treatment of patients after product approval.
The following graphic summarizes the treatment process:
Therapy with less risk of rejection
Aastrom’s patented culturing technology enables the replication of these naturally occurring cells during a 12-day process in a highly automated, aseptic, fully-closed system. The patient-specific cell product resulting from this process contains a mixture of expanded cells to support the regeneration of cardiovascular tissue.
Aastrom’s manufacturing process works exclusively with adult cells derived from and administered to the same patient. As such, Aastrom’s CLI therapeutic approach increases the likelihood of integration with the surrounding tissues, eliminating the need for immunosuppressive drugs. Aastrom’s use of patient-specific cells also avoids the controversies frequently associated with other therapies utilizing stem cells.
After cell processing has occurred, the product is returned to the physician in an aseptic bag. The physician then injects the cells intramuscularly within 3 days of manufacture.