Aastrom receives manufacturing license at facility for production of stem cell products

By E. Janene Geiss

Philadelphia, May 10 - Aastrom Biosciences, Inc. announced Wednesday that it has received a human pharmaceuticals manufacturing license, through its wholly owned subsidiary, for the production of the company's Tissue Repair Cell products.

This is the first manufacturing license issued to Aastrom in the European Union and it enables Aastrom to produce its human cell and tissue products for clinical use in compliance with E.U. regulations, according to a company news release.

The newly licensed manufacturing facility was established as a collaboration at the Fraunhofer Institute for Interfacial Engineering and Biotechnology in Stuttgart, Germany, Aastrom said.

The company said it is currently involved in several clinical trials that use Tissue Repair Cell-based products for tissue regeneration.

The new 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 Tissue Repair Cell manufacturing process, including Aastrom's patented AastromReplicell System, has been installed and validated at the German site, in compliance with E.U. Good Manufacturing Practices, officials said.

This licensed European facility incorporates the company's proprietary technologies for automated, process-controlled production of reliable, patient-specific cell-based products. Officials said this overcomes what has been a hurdle in the cell-based product industry.

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. Each autologous Tissue Repaid Cell product is manufactured for a specific patient.

Aastrom said it has pioneered a scalable cell/tissue manufacturing process that aids regulatory compliance; traditional cell culture production approaches are manual and lack the advantages of Aastrom's technology, officials said.

Based in Ann Arbor, Mich., Aastrom develops products for the repair or regeneration of multiple human tissues based on its proprietary Tissue Repair Cell adult stem cell technology.

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