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STREPTAVIDIN (SA) BIOSENSORS

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 05/09/2025

Procurement Summary

The VRC Virology Laboratory comprises the Virology, Humoral Immunology, and Structural Biology Sections and related Cores. The goal of the Virology Laboratory is to conduct research to understand better the cellular and molecular regulation of viral gene expression, viral entry into the host cell, optimization of immune responses to gene-based vaccination and correlates of immune protection, assessment of active and passive approaches for HIV-1 vaccine development, and to apply structural biology techniques toward rational vaccine design for emerging and re-emerging infectious diseases. The Vaccine Research Center is developing vaccines for HIV-1 and other viruses. Currently, SBS/SBIS is working on developing vaccines for SARS-CoV-2. Production of wild-type and mutant viral proteins and anti-viral antibodies is critical in vaccine development. Making specific immunogens as probes is critical to isolate antibodies and develop therapeutic agents. Relevant salient characteristics of the required Anti-human IgG Fc Capture Biosensors are that they provide counting label-free detection, low limit of detection, high output screening, small sample volume for the immobilization of human IgG and other proteins containing the human Fc region for their kinetic analysis. The sensitivity, resolution, linearity, zero drift and full-scale drift, range, repeatability and reproducibility of these required biosensors allow for consistency and integrity in the lab results. These biosensors are used on the Octet BLI system that has an estimated price of $561,900. There are no other manufacturers that offer biosensors compatible to this instrument and an equal product does not exist. The impact if the required biosensors are not acquired is that the lab will not be able to run binding/screening, affinity, and kinetic measurements for protein samples. This will hinder the research progress relating to antibody structural studies, vaccine designs, and antibody improvements.

Waiver Rationale Summary

Based on the above market research findings and results from previous brand name or equal synopsis and solicitations posted on SAM.gov, no domestic products that meet the requirements were identified. No domestically manufactured items that meet the Government’s need are mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Historically, only one quote for these foreign supplies has been received when reviewing previous solicitations for Octet Biosensors, no domestic quotes were received. The feasibility of foregoing the requirement or providing a United States-manufactured substitute has been considered and no substitutes were found. Authority is requested to acquire the above-described Streptavidin (SA) Biosensors that are manufactured in China by Sartorius Corporation for the total of $12,500.00.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

Yes

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

325414 - Biological Product (except Diagnostic) Manufacturing

Date Submitted

03/28/2025

Procurement Instrument Identifier (PIID)

N/A

Solicitation ID

N/A

Procurement Stage

Pre-solicitation

Expected Maximum Duration of the Proposed Waiver

0 - 6 months

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH