Clearance of Pathogens Causing Diarrhea, Dysentery and Urinary Tract Infections

Phase II Technical Objectives and Key ResultsThe technical objectives of this Phase II effort will be to: 1) Sequence the bacteriophages in the cocktail to establish Quality Control (QC) measures for verification and reproducibility in manufacturing; 2) Conduct advanced in vitro efficacy testing to establish kill curve analysis, dose dependent ranges, and yield product stability including phage cocktail titration  data; 3) Establish GRAS (Generally Recognized as Safe) eligibility via safety studies and data evaluation; 4) Draft standard operating procedures (SOPs) governing the production, purification, handling, batch consistency/quality control and storage requirements for the bacteriophage cocktails; 4) Demonstrate production capabilities via a pilot production run of the bacteriophage cocktails according to the established SOPs.  Due to the highly specialized activities associated scientific research fifty percent of activities will be performed by subcontractors.