A method for sterilization of human plasma and platelets
Department of Health and Human Services
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Small Business Information
AMULET PHARMACEUTICALS, INC.
1450 S ROLLING RD, BALTIMORE, MD, 21227
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): This proposal is to develop a method to prolong the shelf-life and increase the safety of human platelets with a unique method of sterilization. The method delivers an agent known to kill a range of microbial pathogens in vitro including many bacterial species known to contaminate platelet concentrates, fungi, parasites, and viruses. The lethal agent can be released from an insoluble polymer that can be incorporated into the plastic that comprises the collection bag. The microbicide breaks down rapidly to normal physiological by-products, presenting little danger to the patient. Successful development of this method will increase the safety of the platelet and plasma supply, and, by inhibiting microbial growth, increase the shelf-life of platelets. The focus of the effort will be to develop a storage container made from polymers that release sufficient quantities of the lethal agent. Alternative strategies include increasing the polymer surface area, via alterations in the storage container, that will allow release of sufficient lethal agent for efficacy. Antimicrobial spectra of the lethal agent will continue to be assessed before and during prototype stages. Physiological assessments of the effects of the lethal agent on platelets will be performed. Prototype containers will be tested under blood bank conditions. PROPOSED COMMERCIAL APPLICATION: Not Available
* information listed above is at the time of submission.