FDA Science and Research: Keeping stored platelets free of bacteria

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

On 19 November, the FDA informed at their website about a publication in Transfusion 2013 Jun 30. doi: 10.1111/trf.12318.with the title "Preclinical safety evaluation of human platelets treated with antimicrobial peptides in severe combined immunodeficient mice".
The Authors, the FDA scientists Marta Bosch-Marcé, Ketha V.K. Mohan, Monique P. Gelderman, Patricia L. Ryan, Estelle Russek-Cohen and Chintamani D. Atreya "have demonstrated in animal studies a proof-of-concept approach that might reduce the bacterial burden of room temperature stored human platelets. Platelets are used to treat patients for a variety of disorders, including excessive bleeding from wounds and immune system dysfunction." 

"They showed that treating platelet concentrates with molecules called antimicrobial peptides (AMPs) eliminates bacterial contamination of these cells. AMPs are small protein-like molecules that kill bacteria, viruses, fungi, and protozoa. A wide variety of organisms, including humans, produce AMPs. Platelet concentrates are platelets that are stored in plastic bags after much of the plasma (liquid part of blood) in which they normally are suspended in the bloodstream has been removed."

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