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Aastrom Biosciences patents cassette approach to growing human cells.

Aastrom Biosciences, Inc. (Ann Arbor, MI; 734-930-5777) announced that it received United States Patent 6,228,635 entitled, "Portable Cell Growth Cassette for Use in Maintaining and Growing Biological Cells." The new patent provides coverage for inoculating, maintaining, growing and harvesting human cells ex vivo in a cassette chamber format, without exposing the cells to the external environment. This patent also includes coverage of Aastrom's novel software approach to controlling and automating the steps involved in the cell growth process. The cell cassette covered by this patent expands earlier system and device claims for Aastrom's capabilities to grow high quality human cells intended for therapeutic uses.

"Our proprietary cassette approach to producing cells provides a unique, sterilely-closed environment for the automated, Good Manufacturing Practice (GMP)-compliant production of highly functional and robust cells," said R. Douglas Armstrong, PhD, President and Chief Executive Officer of Aastrom. "We continue to broaden our diverse intellectual property base that includes our processes for growing human cells, our proprietary devices to implement those processes at clinical scale, and importantly our clinical systems to automate the cell production process in compliance with GMP's."

The field of cell therapy is being fueled by numerous discoveries for growing and producing human stem and other cells that can then be used as therapeutic treatments. However, developing a standard means for producing these cells with high reliability and under conditions that are compliant with the increasingly strict regulatory requirements, has become a major limitation to moving these research laboratory discoveries into general medical use. The cell cassette covered by Aastrom's new patent , when operated with the other closed-system components of the AastromReplicell System, is being developed as an effective means to overcome this general limitation.

Aastrom is pioneering the development of proprietary cell therapeutics and cell products based on its dual-technology platforms: patented "single-pass perfusion" providing cells with enhanced biological function, and patented GMP-compliant system automation facilitating the delivery of cells for therapeutic use into medical practice. These technologies are integrated into the AastromReplicell System that is designed to uniquely standardize and automate the processes involved in producing high quality therapeutic cells. Aastrom is developing the DC-I dendritic cell product for use in the rapidly emerging cancer vaccine market, and the OC-I bone progenitor cell product for the treatment of degenerative bone diseases such as osteoporosis. The AastromReplicell System, the SC-I bone marrow stem cell product and the CB-I cord blood cell product have received CE Mark approval necessary for European marketing and are in late-stage United States clinical trials. These products are not available for sale at this time in the United States, except for research or investigational use.
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Comment:Aastrom Biosciences patents cassette approach to growing human cells.
Publication:BIOTECH Patent News
Article Type:Brief Article
Geographic Code:1USA
Date:May 1, 2001
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