Isolagen plays its ACE card
which claims to harvest cells more cost-effectively than other cell
harvesting systems currently available. The system will reduce the
time needed by research and commercial labs that grow cells,
ensuring consistency of cell growth and reducing culture
contamination.
The ACE unit consists of two parts. The first is a permanent unit, housing circuitry, pumps and a thermo-electric heater. The second part is the disposable unit, which contains a "cell tower," media bags, cell separator and a sterile tubing for media flow.
Cells are placed within the cell tower, which is designed to accommodate the growth of the cells, eliminating the time-consuming transfer of growing cells into new flasks. Every step, from feeding the cells to the harvesting of the injection syringes, will be executed in a sterile, closed-loop system.
"We've invested significant resources to make the cell propagation process scalable and consistent," said Isolagen's Chairman Frank DeLape. "The Automated Cellular Expansion (ACE) System is a solution that should enable us to introduce the Isolagen Process on a global scale, and will allow us to pursue licensing opportunities with organisations engaged in cell propagation and harvesting," he added.
Isolagen's Isolagen Process in which a patient's own cells are used to correct and reduce the normal effects of aging and replenish deficiencies caused by the loss of fibroblast cells as a person ages. An aesthetic dermal application is currently available in the UK and is in Phase III clinical trials in the US. A Biologics License Application is expected to be filed with the FDA in late 2005.
The design eliminates nearly all-human intervention, reducing contamination and technical labour and monitoring associated with the process. The footprint of the Isolagen ACE unit is designed for modular stacking and maximum space efficiency.
The ACE design secures and records the identification of each patient's cells through every step of the process, from biopsy to injection, creating a clear electronic chain of custody. Cells will be contained in a cell tower, which is designed to accommodate the expansion and growth of the cells and monitor cell growth and cell count to effectively predict when the target number of cells will be reached. In addition, Isolagen intends to utilise cryogenic preservation and freezing technology to allow maximum flexibility in scheduling treatments.
"The original business plan for Isolagen called for a single lab in every country, so the concept of scalability was not a priority," said DeLape. "We envision a single laboratory serving multiple continents utilising an efficient method of cell propagation and harvesting on a commercial scale."
"Following the anticipated successful implementation of ACE for the Isolagen Process, we intend to seek licensing opportunities with other cell-based companies thereby creating a new revenue stream for our shareholders," he added.
Isolagen intends to introduce ACE technology in the UK and its new Swiss facility during 2006. This facility in Neuchatel, Switzerland intends to service Europe, Asia and Africa, and the purchase of a lab in Exton, PA to service the Central and South America and the United States once FDA approval is obtained.
