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Justification, first published as presolicitation

Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody

NOI-NIAID-24-2226773

National Institutes of Health, National Institutes of Health Niaid. Pharmaceutical Preparation Manufacturing.

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Awarded

United Biopharma, Inc.

$400,000.00 obligated so far on USAspending, September 27, 2024, contract 75N93024P01131

Description

As published on SAM.gov.

United BioPharma, is the patent holder and manufacturer for UB-421, and the only company that possesses the cell line necessary for its production. As such, United BioPharma is the only known source to produce this drug. Justification document attached.

The contract, on USAspending

Federal procurement data the awarding office reported to FPDS, matched to this solicitation by its number.

Recipient
United Biopharma, Inc.
UEI
KWMNCKBPM4K6
CAGE
SRXM8
Vendor location
Hsinchu County
Contract
75N93024P01131, purchase order
Obligated
$400,000.00
Actions
2 between September 27, 2024 and April 29, 2025
Competition
Not Competed Under SAP, 1 offer received
Set-aside reported
No Set Aside Used.
Described as
Clinical Grade Monoclonal Antibody UB-421 Includes: One 100-Liter Batch of Gmp-Manufacturer UB-421, Sterile Vialing, and Long-Term and Accelerated Stability Studies.
Match
solicitation number NOINIAID242226773 equals the FPDS solicitation identifier; same awarding office 75N930 (high confidence)
Record
USAspending award page

Publications

Every notice SAM.gov issued under this solicitation number, oldest first. Each is a separate record on SAM.

  1. September 12, 2024

    Presolicitation, originally sources sought

    Due September 20, 2024 at 3:00 PM EDT. SAM.gov, notice 54099bfa8a304a858cfe289e2c604101

  2. October 9, 2024

    Justification, originally presolicitation

    SAM.gov, notice 72a563278ca94cf4b3b5c5edb1fe3ce2

Points of contact

Also open from this buyer