Aastrom Biosciences Gets CE Mark For Dendritic Cell Therapy Product.(Brief Article)

2001 NOV 14 - (NewsRx.com & NewsRx.net) -- Aastrom Biosciences Inc. has obtained approval to affix the CE Mark to the DC-I Cell Therapy Kit for the ex vivo production of human dendritic cells, allowing the company to market and sell the product in Europe. The DC-I product is used to produce Aastrom's proprietary dendritic cell product, the Dendricell, that is intended to provide a base dendritic cell for a broad range of cancer vaccines being developed using cancer-associated antigens.

The DC-I dendritic cell production product utilizes Aastrom's patented single-pass perfusion methodology, for enhanced cell biology and outcome reliability in the production of clinical quantities of dendritic cells. Additionally, the DC-I dendritic cell product is produced in the AastromReplicell System platform, enabling the automated, process-controlled cell production of human dendritic cells in compliance with regulatory requirements for Good Manufacturing Practice (GMP).

"Dendritic cell vaccines are aggressively being explored in the European clinical community," commented Holger Beckmann, managing director of Zellera AG, Aastrom's European subsidiary. "In conjunction with the excellent biological activity of the Dendricell, Aastrom's DC-I product automation addresses a clear need for GMP-compliant dendritic cell production capability, aiding the customers in meeting requirements of European regulatory agencies."

This announcement follows earlier ...