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Stunner Platform – benchtop micro-volume and high throughput protein characterization system

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/24/2023

Procurement Summary

NIAID requires 1x Qty of Part#700-2002; Description: Stunner Platform. This item is manufactured by Labs in Belgium. National Institute of Allergy & Infectious Diseases (NIAID)’s Vaccine Research Center (VRC) (collectively “Program”) is engaged in research to facilitate the development of vaccines against HIV/AIDS and other infectious pathogens/diseases. Program’s goal is to develop immunogens that will elicit broadly neutralizing antibodies and will be used in vaccine design. This research requires equipment that are capable of protein characterization in the form of micro-volume and high throughput protein characterization systems. Program has evaluated one such system called the Stunner Platform created by Unchained Labs, and determined that this system suits its needs for research. This acquisition has certain technical requirements. These requirements include the following: Crucial must have features: -UV/Vis -Dynamic light scattering (DLS) -Static light scattering (SLS) -Minimal amount of sample (< 5 uL) Good to have but not absolutely necessary features: -LNP total RNA quant -AAV & AdV capsid titer Max dimensions ‐ 37 cm W x 54 cm D x 33 cm H; <35 kg UV/Vis specifications Light source ‐ Xenon flash lamp Detectors ‐ UV/Vis polychromatic spectrophotometer Wavelength ‐ range230‐750 nm Wavelength accuracy ‐ ≤400nm: ±1nm; ≥400nm: ±2 nm Spectral resolution ‐ Better than 2 nm (toluene in hexane) Absorbance precision (1 cm quartz cuvette) <1 OD: ±0.005 OD; st dev 1‐2 OD: ±0.5% CV Absorbance accuracy (1 cm quartz cuvette) <1 OD: ±0.01 OD; 1‐2 OD: ±1% DLS specifications Light source ‐ 660 nm laser diode Detection ‐ Avalanche photodiode module Size accuracy ‐ ±2% Minimum sample concentration ‐ 0.1 mg/mL lysozyme Hydrodynamic diameter range ‐ 0.3–1000nm Samples per plate 96 (12 x 8 microplate format) Measurement time for full plate ‐ <20 minutes for UV/Vis only; <90 min for UV/Vis and DLS Measurement range: OD 10 mm ‐ 0.03–275 OD ng/μL dsDNA ‐ 1.5–13750 ng/μL mg/mL ave protein mix ‐ 10 mm 0.03–275 mg/mL Absorbance precision (10 mm pathlength) <1 OD: ±0.01 OD; st dev 1‐200 OD: ±1% CV Absorbance accuracy (10 mm pathlength)<1 OD: ±0.02 OD; 1‐200 OD: ±2% To our knowledge, only this Stunner platform from Unchained Labs can meet the requirements of Program, and this platform is made in a foreign country of Belgium.

Waiver Rationale Summary

Based on the above market research findings and results from the brand name or equal request for quotes RFQ-NIAID-23-2172175 posted on SAM.gov, no domestic products that meet the requirements were available. No domestically manufactured items that meet the Government’s need that are mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of satisfactory quality could be identified. Only one company responded to the solicitation (Request for Quotes), which was posted as full and open competition with a brand name or equal requirement, and that was Unchained Labs. 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 Stunner Platform, manufactured by Unchained Labs in Belgium. Based on the findings detailed above, the Stunner Platform, manufactured by Unchained Labs are not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Therefore, it is hereby determined by NIAID, consistent with FAR 25.103(b)(2), that these items are not domestically available.

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?

No

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

08/21/2023

Procurement Instrument Identifier (PIID)

N/A

Solicitation ID

RFQ-NIAID-23-2172175

Procurement Stage

Post-solicitation

Expected Maximum Duration of the Proposed Waiver

0 - 6 months

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH