SBIR-STTR Award

Method for Sterilization of Human Plasma and Platelets
Award last edited on: 5/15/20

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$1,240,275
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Robert R Raulli

Company Information

Amulet Pharmaceuticals Inc (AKA: Dorlin Pharmaceuticals Inc~ChekTec Corporation)

9430 Key West Avenue Suite 120
Rockville, MD 20850
   (910) 392-9800
   info@amuletpharma.com
   www.amuletpharma.com
Location: Single
Congr. District: 08
County: Montgomery

Phase I

Contract Number: 1R43HL062729-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
1999
Phase I Amount
$99,700
This proposal is to develop a method to prolong the self-life and increase the safety of human platelets with a unique method of sterilization. The method delivers an agent known to kill a broad range of microbial pathogens in vitro including bacterial species known to contaminate platelet concentrates, as well as 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 agent breaks down rapidly to normal physiological by-products, and thus presents 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 shelf-life of platelets. Human plasma will be inoculated with common microbial contaminants of human platelet concentrates, and experiments performed to determine agents with optimal half-lives for antimicrobial efficacy. Efficacious compounds will then be tested in human platelet concentrates under blood bank conditions of handling and storage. Assessment of the effects of the compounds on the physiology of platelets will also be determined. PROPOSED COMMERCIAL APPLICATIONS: Successful development of a simple, inexpensive and effective process to sterilize plasma and platelet concentrates has the potential to become incorporated into every plasma and platelet collection container produced, roughly 20 million each year in the US. The economic incentive for this project is to develop agents to sterilize, and thus, prolong platelet shelf- life. The ability to significantly increase shelf-life of platelet concentrates could save blood banks millions of dollars each year.

Thesaurus Terms:
antibiotic, antiseptic sterilization, method development, plasma, platelet, tissue /cell preparation blood bank, morphology human tissue

Phase II

Contract Number: 2R44HL062729-02A1
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2001
(last award dollars: 2003)
Phase II Amount
$1,140,575

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.

Thesaurus Terms:
antibiotic, antiseptic sterilization, blood bank, blood bank /supply contamination, method development, platelet preservation, tissue /cell preparation nitric oxide, packaging material, polymer human tissue