Post by icemandios on May 24, 2017 15:28:57 GMT
From Cerus Corp:
"On May 23, 2017, Cerus Corporation (the “Company” or “Cerus”) announced that it had received notification last week of a pending U.S. supply shortage of a platelet additive solution (“PAS”) manufactured and sold by Fresenius Kabi Deutschland GmbH (“Fresenius Kabi”). The pending shortage is due to an unanticipated delay in U.S. Food and Drug Administration (“FDA”) approval of a plastic component used in the manufacture of the PAS container following discontinuation of the original component by Fresenius Kabi’s supplier. The shortage is expected to temporarily impact certain U.S. blood centers that utilize PAS to produce INTERCEPT platelets. Fresenius Kabi has stated that it is working with its suppliers and the FDA to resolve this delay and minimize any long-term disruption in supply. However, Cerus believes that the pending shortage could adversely affect INTERCEPT platelet production by impacted blood centers through year end. "
Wouldn't want patients injured by possible toxicity arising from the new plastic component in the container.
Far better to have the patients injured by pathogens in the blood or serum which is what the INTERCEPT process prevents:
"The INTERCEPT™ Blood System for platelets and plasma employs the unique properties of a specially developed molecule, amotosalen HCl, to irreversibly block the replication of DNA and RNA, preventing the proliferation of susceptible pathogens."
interceptbloodsystem.com/blood-center/intercept
"On May 23, 2017, Cerus Corporation (the “Company” or “Cerus”) announced that it had received notification last week of a pending U.S. supply shortage of a platelet additive solution (“PAS”) manufactured and sold by Fresenius Kabi Deutschland GmbH (“Fresenius Kabi”). The pending shortage is due to an unanticipated delay in U.S. Food and Drug Administration (“FDA”) approval of a plastic component used in the manufacture of the PAS container following discontinuation of the original component by Fresenius Kabi’s supplier. The shortage is expected to temporarily impact certain U.S. blood centers that utilize PAS to produce INTERCEPT platelets. Fresenius Kabi has stated that it is working with its suppliers and the FDA to resolve this delay and minimize any long-term disruption in supply. However, Cerus believes that the pending shortage could adversely affect INTERCEPT platelet production by impacted blood centers through year end. "
Wouldn't want patients injured by possible toxicity arising from the new plastic component in the container.
Far better to have the patients injured by pathogens in the blood or serum which is what the INTERCEPT process prevents:
"The INTERCEPT™ Blood System for platelets and plasma employs the unique properties of a specially developed molecule, amotosalen HCl, to irreversibly block the replication of DNA and RNA, preventing the proliferation of susceptible pathogens."
interceptbloodsystem.com/blood-center/intercept