Salivary Gland System for the Production of Therapeutics

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43DE017079-01
Agency Tracking Number: DE017079
Amount: $100,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2005
Solicitation Year: 2005
Solicitation Topic Code: N/A
Solicitation Number: PHS2005-2
Small Business Information
P.O. Box 252, East Woodstock, CT, 06244
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (860) 963-2612
Business Contact
Phone: (212) 554-6856
Research Institution
DESCRIPTION (provided by applicant): The overall objective of this proposal is to investigate the feasibility of the ruminant salivary gland as a system for the production of therapeutic human proteins. Protein therapeutics is currently in increased demand for the treatment of disease. Existing production systems have limitations such as low capacity, high cost and lack of appropriate post-translational protein modifications. Our novel system can potentially overcome all these limitations. Our specific aim is to direct the expression of a human plasma protein to the salivary gland of transgenic goats, and to achieve secretion of the recombinant protein in saliva. Ruminants produce copius amounts of saliva daily, which is highly buffered but low in protein content. The negligible protease content allows for secretion of intact, under graded protein. These are significant advantages over the purification of recombinant proteins from proteinaceous fluids, like milk or plasma. We propose to use nuclear transfer to generate transgenic animals and have chosen to work with goats due to their short gestation period compared to cows. We will also develop a method for the long-term collection of saliva. Preliminary work in cows suggests that the salivary ducts can be readily accessed for collection. Phase I support will be used to generate salivary gland-specific transgenes, establish fetal cell lines and transgenic animals using nuclear transfer, as well as, to optimize saliva collection, processing and assay development. These data will be used to design future Phase II studies with optimized constructs to generate more animals, followed by the collection of transgenic saliva, and purification of the functional recombinant protein.

* information listed above is at the time of submission.

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