Inactive Total Small Business Set-Aside (FAR 19.5)

The emergence of SARS-CoV-2 variant viruses has elicited a surge of requests to several clinical trial companies and investigators for access to vaccinee and convalescent sera for use in efficacy stud... The emergence of SARS-CoV-2 variant viruses has elicited a surge of requests to several clinical trial companies and investigators for access to vaccinee and convalescent sera for use in efficacy studies of COVID-19 medical countermeasures (MCMs). As these requests are expected to persist, the U.S. Government is creating a new centralized serum repository to ensure the availability of these samples for continued assessments of MCM efficacy against new and existing variant viruses and thereby lessen the burden these requests are currently placing on vaccine companies. To this end, there is an urgent need to source and convert (to serum) plasma from individuals who are COVID-19-naïve and have undergone COVID-19 vaccination under FDA-issued Emergency Use Authorization and from individuals who have been infected with SARS-CoV-2 variants of concern and interest. The purpose of this acquisition is to acquire defibrinated plasma. The successful offeror will have the capacity and operational infrastructure to convert plasma to serum (defibrinate) and subsequently aliquot, label, freeze, package, and ship the defibrinated plasma to a U.S. Government-selected storage and distribution facility. The defibrinated plasma must meet the U.S. Government’s specifications set forth in the attached Purchase Description. The Government will conduct a quality audit of the facility pre-award to ensure vendor capabilities and quality controls. See attached BARDA CSS 75A50121R00039 with Attachments.