The Community Blood Center (CBC) Receives FDA Approval for Interstate Distribution of Pathogen-Reduced Platelets
APPLETON, Wis., March 13, 2018 /PRNewswire/ — As blood resources nationwide are being closely examined to prevent the risk of transmitted infections during blood transfusions, one Wisconsin blood bank is proud to announce a new technology that will help to further its commitment to ensuring the safety of patients.
The Community Blood Center (CBC) of Appleton, Wisconsin, has been granted approval by the U.S. Food and Drug Administration (FDA) on their Biologics License Application (BLA) to distribute platelets that have been pathogen-reduced with the INTERCEPT Blood System, becoming the first in the state of Wisconsin to receive this approval. The INTERCEPT Blood System is provided through Cerus, a biomedical company that specializes in blood safety. Central to its mission to “Connect Lives, Share Life,” CBC is honored to deliver this new technology to further ensure the safety of the patients and hospitals that it serves.
“Our BLA approval will enable us to supply INTERCEPT-treated platelets for patient care within Wisconsin and throughout the United States,” commented John Hagins, CBC’s president and chief executive officer. “Through increased availability of pathogen reduced products, we can help our hospitals protect patients from transfusion-transmitted infections, including from bacteria and newly emerging pathogens.”
In the United States, the incidence of transfusion-transmitted infections (TTIs), including HIV, and hepatitis C (HCV), have all but been eliminated thanks to donor screenings and advanced disease testing procedures; however, residual risk particularly due to bacteria and emerging pathogens, still exists. Bacterial contamination of platelets is known as one of the most significant infectious risks due to transfusion, with an estimated contamination rate of 1 in every 1,500 platelet units.
The INTERCEPT Blood System employs pathogen reduction, a proactive approach to reducing transfusion-transmitted infectious risk, including infection, through the deactivation of bacteria, viruses, parasites, and white blood cells in platelet components.
The Biologics License Application is a common procedure for blood centers to request permission by FDA to introduce a biologic product into interstate commerce (21 CFR 601.2). Until a blood center obtains a BLA, they are restricted to distributing INTERCEPT-treated products to hospitals within the state in which they are produced.
Every blood donation provides for a lifetime of possibilities for family members, neighbors and friends being treated in local hospitals. Because there is no substitute for blood, generous blood donors are needed every day.
The Community Blood Center was established in 1955 and continues today as an independent non-profit organization providing a safe and reliable blood supply to hospitals in Northeast Wisconsin, the Northwoods and upper Michigan. CBC has donor centers in Appleton, Oshkosh, Little Chute and Woodruff, and hosts over 100 blood drives every month. For more information on donating blood or hosting a blood drive, please visit communityblood.org or call (800) 280-4102.
Cerus is a biomedical company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood.
CONTACT: Tyler Sjostrom, 920-560-6650, firstname.lastname@example.org
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SOURCE The Community Blood Center