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Producing Humanized Therapeutics in Avian Egg White

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI055068-02
Agency Tracking Number: AI055068
Amount: $623,937.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: PHS2006-2
Timeline
Solicitation Year: 2006
Award Year: 2006
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
AVIGENICS, INC. GEORGIA BIOBUSINESS CENTER
ATHENS, GA 30605
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 LEANDRO CHRISTMANN
 () -
Business Contact
 TONY CRUZ
Phone: (706) 227-1170
Email: CRUZ@AVIGENICS.COM
Research Institution
N/A
Abstract

DESCRIPTION (provided by applicant): This phase II SBIR project will test the feasibility of producing large amounts of human monoclonal antibody into transchromosomic avian egg white. We will use a full length ovomucoid genomic locus expression construct created and tested in phase I, to drive expression of the monoclonal's heavy and light chain cDNA. Using these constructs we produced transgenic hens that expressed human monoclonal antibody into their egg whites. This antibody was purified and analyzed for antigen binding and effector function. The results of this analysis support the conclusion that the transgenic produced antibody exhibits antigen binding and effector function that is comparable to the same antibody produced in a mammalian cell culture. This phase II project will also utilize an improved gene delivery system to generate fully transchromosomic avian hens. We have recently generated transchromosomal founders that exhibit germline transmission of a 60MB artificial chromosome. The offspring of these birds contain single copies of the artificial chromosome in every cell. This represents a breakthrough in avian transgenesis which to this point has been restricted by the limited payload capacity of retroviral-mediated methods. We will utilize this improved avian transgenisis technique to deliver the two ovomucoid-based human monoclonal antibody expression vectors developed in phase I to stage I embryos. Transgenic human monoclonal antibody from GO, G1 and G2 birds will be analyzed for expression level, purified and characterized for bioactivity and glycosylation. We anticipate that the G2 production flock will be able to supply sufficient human monoclonal antibody to proceed to clinical trials.

* Information listed above is at the time of submission. *

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