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Title: Regulatory steps associated with use of value-added recombinant proteins and peptides screened in high-throughput for expression in genetically engineered starch and cellulosic fuel ethanol yeast strains

Author
item Hughes, Stephen
item CHEN, HELEN - AMBRYX
item TSAI, DAVID - AMBRYX
item THOMPSON, W. JOSEPH - WJTECH, INC.
item Dowd, Patrick
item HOOBERMAN, BARRY - FDA, CVM
item BENJAMIN, LINDA - FDA, CVM
item Alexander, Leeson
item Rosentrater, Kurt
item Rich, Joseph

Submitted to: Meeting Abstract
Publication Type: Abstract Only
Publication Acceptance Date: 11/5/2007
Publication Date: 11/5/2007
Citation: Hughes, S.R., Chen, H., Tsai, D., Thompson, W., Dowd, P.F., Hooberman, B., Benjamin, L., Alexander, L.J., Rosentrater, K.A., Rich, J.O. 2007. Regulatory steps associated with use of value-added recombinant proteins and peptides screened in high-throughput for expression in genetically engineered starch and cellulosic fuel ethanol yeast strains [abstract]. FDA Meeting. Talk 1.

Interpretive Summary:

Technical Abstract: Recombinant proteins expressed in animals have been a public concern as a perceived risk to the consumer. Animals are currently being treated with genetically engineered biologicals, such as growth hormone, or fed genetically modified plants. Similarly, various commercially-valuable proteins or peptides that could be expressed in fuel ethanol yeast strains will possibly be found in the dried distillers grains (DDGS) used as feed for cattle, pigs, chickens, and catfish. These proteins and peptides are becoming more important for improving the nutritive quality of feed and veterinary biological purposes, as well as for delivery of the feed to the farm. Here we discuss several nutritional, insecticidal, and therapeutic peptides that are expressed in yeast strains capable of fermenting ethanol. The insecticidal peptide that we have characterized was optimized on an automated robotic platform in order to optimize activity against a test insect. Another peptide we are pursuing is a pharmaceutical for veterinary use; that is, a potential antitumor biological to treat cancer in cattle and chickens. We will examine the regulatory requirements for this use. Discussions will focus on applicable regulations from FDA, USDA, EPA, and the feed board with responsibility for regulating this type of product. In addition, another area to be considered is the production of polymeric proteins and growth promoting peptides in yeast to make the feed more transportable and more nutrient rich.