Aastrom achieves manufacturing milestone: new generic name for cell therapy product.
Ann Arbor, Mich.-based Aastrom Biosciences, Inc. (Nasdaq: ASTM) said it has completed an important product manufacturing milestone with the transfer of cell cassette manufacturing to ATEK Medical under a partnership announced in October 2010.
The single-use cell cassettes are the central component used in Aastrom's proprietary culturing process at its cell manufacturing facility in Ann Arbor.
"As a result of this milestone, which we achieved ahead of schedule, we now have a fully validated and reliable manufacturing partner to support our late stage clinical development programs," said Aastrom CEO Tim Mayleben. "This will ensure that Aastrom has the inventory of high-quality cell cassettes necessary for the planned mid-2011 start of our Phase 3 clinical program in critical limb ischemia."
In addition, Aastrom announced that ixmyelocel-T has been formally accepted by the U.S. Food and Drug Administration's Center for Biologies Evaluation and Research and the United States Adopted Names Council as the nonproprietary name for Aastrom's investigational cell therapy product.
"We also reached an important product development milestone with the selection of ixmyelocel-T as the generic name of our expanded cell therapy product," Mayleben said. "This name was reviewed and accepted by the FDA and USAN Council and will be used by us and our collaborators going forward."
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|Title Annotation:||Strategic Alliances|
|Publication:||Stem Cell Business News|
|Date:||Apr 11, 2011|
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