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Title: Regulatory concerns associated with use of value-added recombinant proteins and peptides screened in hgh-throughput for expression in fuel ethanol yeast strains

Author
item Hughes, Stephen
item Dowd, Patrick
item Hector, Ronald - Ron
item Bischoff, Kenneth
item Rich, Joseph
item Cotta, Michael
item Slininger, Patricia - Pat
item Rosentrater, Kurt
item CHEN, HELEN - AMBRYX
item TSAI, DAVID - AMBRYX
item THOMPSON, JOSEPH - WJT TECH, INC.
item Alexander, Leeson
item BUTT, TAUSEEF - LIFESENSORS, INC.
item STERNER, DAVID - PROGENTRA, INC.
item BENJAMIN, LINDA - FDA, CVM
item HOOBERMAN, BARRY - FDA, CVM
item PANAVAS, TADAS - LIFESENSORS, INC.
item BUTT, TAUSEEF - LIFESENSORS, INC.

Submitted to: Meeting Abstract
Publication Type: Abstract Only
Publication Acceptance Date: 1/30/2008
Publication Date: 1/30/2008
Citation: Hughes, S.R., Dowd, P.F., Hector, R.E., Bischoff, K.M., Rich, J.O., Cotta, M.A., Slininger, P.J., Rosentrater, K.A. 2008. Regulatory concerns associated with use of value-added recombinant proteins and peptides screened in hgh-throughput for expression in fuel ethanol yeast strains [abstract]. LabAutomation 2008, Track 5, Seminar 4. p. 5.

Interpretive Summary:

Technical Abstract: Recombinant proteins expressed in animals have been a public concern as a risk to the consumer since the animals are genetically modified to obtain desired improvements (GMO animals). Similarly, various commercially valuable proteins or peptides expressed in fuel ethanol yeast strains under development to increase cost-effectiveness of the process 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 feed for nutrition and veterinary biological purposes as well as for delivery of the feed to the farm. Here we discuss several peptides that are expressed in fuel ethanol yeast strains for nutritional, insecticidal, and therapeutic uses. The insecticidal peptide that we have characterized was optimized on the automated robotic platform to generate the most lethal mutant against a test insect. Each of the peptides that are of interest will be subjected to this robotic screening. 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 application. 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 to make the feed more transportable and more nutrient rich in essential amino acids.