Cerus has received regulatory approval from the US Food and Drug Administration (FDA) for the manufacture of INTERCEPT plasma with a new, alternative plastic disposable kit.
The conversion to the new kit is in conjunction with the company’s long-existing strategy to advance its global supply chain integrity.
The new system is designed to reduce the risk of transfusion-transmitted infections by a pathogen, reducing a wide range of viruses, bacteria, protozoa and contaminating donor leukocytes in plasma components.
It demonstrates robust inactivation of several members of the coronavirus family, including SARS-1 COV and MERS CoV.
According to the company, the use of the INTERCEPT system in the processing of Covid-19 convalescent plasma cuts down the risk of transfusion-transmitted infections from existing and emerging pathogens and retains antibody titers.
The use of a licensed pathogen technology is required to reduce the risk of transfusion-transmitted infections and alleviate concerns about potential superinfections with SARS-CoV-2, noted the company referring to a published document by the International Society of Blood Transfusion Working Party on Global Blood Safety.
Cerus president and CEO William Greenman said: “The FDA approval for the new INTERCEPT plasma kit is significant as it is a prerequisite for our planned PMA-S submission for pathogen reduced cryoprecipitate, expected this quarter.
“In addition, the approval is important, given the renewed interest in convalescent plasma as a promising treatment for those afflicted with Covid-19.”