Clinical Human Cell Production System for Broad Use

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$798,266.00
Award Year:
2005
Program:
SBIR
Phase:
Phase II
Contract:
9R44NR009855-02
Agency Tracking Number:
EB000955
Solicitation Year:
2005
Solicitation Topic Code:
n/a
Solicitation Number:
PHS2005-2
Small Business Information
AASTROM BIOSCIENCES, INC.
Domio'S Farms. Lobby L, 24 Frank Lloyd Wright Dr., Ann Arbor, MI, 48105
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
BRIAN HAMPSON
(734) 930-5571
BHAMPSON@AASTROM.COM
Business Contact:
ALAN WRIGHT
(734) 930-5555
AWRIGHT@AASTROM.COM
Research Institution:
n/a
Abstract
The therapeutic potential of patient-specific cultured cells continues to rapidly grow for a range of medical needs, such as regenerative repair of damaged tissue, cancer, and infectious diseases. As a result, the motivation to commercialize patient-specific "cell products" is increasing rapidly as well. A large unmet need exists for the development of reliable clinical and commercial ceil manufacturing capability for these cell products in compliance with increasingly strict regulatory guidelines and where the production economics are more favorable so that the benefits of cell therapy can be more widely enjoyed. In Phase I, a prototype system was defined and constructed that incorporated Aastrom's single-pass perfusion technology for highly effective primary human cell production along with a sterile, closed fluid path and a robotic instrument to perform operational steps (e.g. priming, inoculation, harvest). The approach provides general flexibility to enable researchers to develop and optimize a wide range of production processes, over a variety of cell types, as well.as cost-effective scale-up to clinical and commercial cell manufacturing. A non-adherent T-Cell process and an adherent stromal cell process were successfully demonstrated with the prototype. In Phase II, process control methods and additional automation technology will be developed, a modular configuration strategy will be defined, system components developed to enable cell manufacturing over a wide range of scale, and a test configuration constructed and tested to validate the design. Successful completion of Phase II will provide the technology and results necessary to initiate a commercialization phase to include both the use of the modular system as component technology to support commercialization of Aastrom's proprietary Tissue Repair Cell (TRC) products as well as the direct commercialization of the system for use by other institutions planning to commercialize therapeutic cell products.

* information listed above is at the time of submission.

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