GMP Manufacturing of CDC FluSC2 Multiplex EUA Kit
ID: 75D30123C16444Type: Justification
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFCENTERS FOR DISEASE CONTROL AND PREVENTIONCDC OFFICE OF ACQUISITION SERVICESATLANTA, GA, 30333, USA

PSC

IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS (6550)

Original Source

https://sam.gov/opp/a71d247741944ec1b3c3cda9c9183401/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), has awarded a contract for the GMP manufacturing of the CDC FluSC2 Multiplex EUA Kit to Biosearch Technologies, Inc. This contract, valued at $399,993, entails the production of 1,020 vials of oligonucleotide primers and probes, adhering to Good Manufacturing Practices (GMP) as defined under 21 CFR 820, with a required delivery date of September 25, 2023. The specific internal BHQnova quencher design of the probes is critical for the diagnostic assay, which has received Emergency Use Authorization (EUA) from the FDA, and no other suppliers have been identified that can meet these stringent requirements. For further inquiries, interested parties may contact Mark Draluck at syq1@cdc.gov or Devin Barich at uca9@cdc.gov.

    Point(s) of Contact
    Mark Draluck
    (770) 488-0938
    syq1@cdc.gov
    Devin Barich
    uca9@cdc.gov
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    JA Redacted.pdf
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    GMP Manufacturing of CDC FluSC2 Multiplex EUA Kit
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