Transgenic Plant Technology for Producing Therapeutic Recombinant Antibodies

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$100,001.00
Award Year:
2005
Program:
SBIR
Phase:
Phase I
Contract:
1R43CA117211-01
Award Id:
75556
Agency Tracking Number:
CA117211
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
Altor Bioscience Corporation, 2810 N Commerce Pky, Miramar, FL, 33025
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
VALENTIN NEGROUK
(954) 443-8600
VNEGROUK@ALTORBIOSCIENCE.COM
Business Contact:
(954) 443-8600
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): The need to develop novel, cost effective manufacturing processes to produce therapeutic antibodies commercially will continue to be of considerable and growing interest to biopharmaceutical and medical industries. The long-term objectives related to this application are to develop novel manufacturing processes using stable transgenic plants, namely Arabidopsis and lettuce, to improve the production process and demonstrate the feasibility and advantages of the manufacturing technology. These objectives are best accomplished by developing high yielding transgenic plants producing a model antibody and demonstrating the antibody's functionality by extensive characterization and testing in comparison with the same antibody produced in mammalian cell culture. The model antibody used for assessing the technology and comparison purposes is a fully humanized IgGlK anti-tissue factor antibody (hOAT) that is currently in pre-clinical development as an anti-cancer therapeutic. The specific aims of this research proposal are to: i) develop lines of stable transgenic Arabidopsis and lettuce producing high yields of hOAT and produce 100 mg of hOAT antibody produced by stable transgenic lettuce; and ii) characterize the plant-derived hOAT to evaluate comparability to CHO-produced hOAT using in vitro testing (activity, protein characteristics), pharmacokinetics and in vivo anti-cancer efficacy in a mouse xenograft model. The plant-based system described would be one oUhe most economical processes for antibody production and could make it possible to produce these therapeutic proteins at significantly lower cost of goods, enabling wider spread use of antibody therapeutics, particularly in less economically developed markets. The use of hOAT as model protein will provide proof-of-principle, demonstrate production economics and antibody functionality/efficacy and also lead to a plant-derived antibody product that could be advanced into clinical studies.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government