Aastrom Biosciences, Inc. has announced that it has received a human pharmaceuticals manufacturing license, through its wholly owned subsidiary, for the production of the Company's Tissue Repair Cell (TRC) products.
This manufacturing license enables Aastrom to produce its human cell and tissue products for clinical use in compliance with EU regulations.
The newly licensed manufacturing facility was established as collaboration at the Fraunhofer Institute for Interfacial Engineering and Biotechnology in Stuttgart, Germany.
The manufacturing site will be used to expand these studies, and will serve as a pilot facility for centralized manufacturing that is a requirement of the Company's commercialization strategy.
The TRC manufacturing process, including Aastrom's patented AastromReplicell® System, has been installed and validated at the German site, in compliance with EU Good Manufacturing Practices (EU-GMP).
"Our successful establishment of a licensed centralized manufacturing facility to produce Aastrom's TRC products for tissue regeneration is an important operational milestone in our commercial business strategy," said R. Douglas Armstrong, Ph.D., Chief Executive Officer and Chairman of Aastrom.
"This authorization provides the Company with a manufacturing capability that can be used for all of our TRC products in clinical development, and demonstrates that Aastrom is successfully advancing autologous stem cell products from research toward commercialization."
This licensed European facility incorporates the Company's proprietary technologies for automated, process-controlled production of patient-specific cell-based products.
Traditional pharmaceuticals are typically produced in a single lot, and used for many thousands of patients; this manufacturing model cannot be used for autologous cell/tissue products.