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Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: Mass Spectrometry Data Analysis Software Upgrade and Expansion

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC, VPP
Address of the requesting lab/office: 9 West Watkins Mill Rd. Gaithersburg, MD 20878

II. Description of the project, and supplies or services required to meet the agency’s needs A. Project Background The VRC/Vaccine Production Program/Analytical Development group is responsible for developing assays that are used to characterize therapeutic and vaccine candidates to treat diseases including Covid-19 (SARS2-CoV), HIV, Influenza, Malaria, and Ebola. Characterizing vaccine candidates is required for moving forward with a candidate to GMP manufacturing and clinical trials. A large amount of data is acquired during the analysis process. Once data is acquired, workflow-specific software is used to analyze data and produce reports.

The goal of this purchase is to update the current software installations and provide additional copies of the software. Currently, only one copy of multiple different software packages is available for multiple users. Due to pandemic-related restrictions, the number of personnel allowed in the lab is reduced, and software package are only available on a single computer in lab. Because of these limitations, data analysis time has increased and results delivery delayed. The purchase of upgrades and additional software allows VRC to increase throughput by decreasing data analysis time while accommodating lab personnel restrictions.

For BioPharma Finder, three new software installations are requested. These new software installations will allow parallel processing of data and eliminate the need to be in lab to process data, increasing sample turnaround time. One BioPharma Finder software upgrade is requested. This software upgrade will update the software on the computer in lab (currently the only installation of the software), ensuring that all versions of software in Analytical Development are the same build and eliminating any incompatibilities in data processing from different computers. Purchasing older versions of BioPharma Finder is not possible, so the upgrade is necessary to maintain consistent software installations across the lab.

For Proteme Discoverer, two new software installations are needed. These two new software installations will allow parallel processing of data and eliminate the need to be in lab to process data, increasing sample turnaround time. One Proteome Discoverer software upgrade is needed. This software upgrade will update the software on the computer in lab (currently the only installation of the software) and activate the missing features, ensuring that all versions of software in Analytical Development are the same build and eliminating any incompatibilities in data processing from different computers. Purchasing older versions of Proteome Discoverer is not possible, so the upgrade is necessary to maintain consistent software installations across the lab.

One new piece of software, Compound Discoverer, is also required. This software is necessary for enabling metabolomics studies that have been requested by other groups in Analytical Development. This software is compatible with our current mass spectrometer as it is has been designed by the mass spectrometer vendor.

B. Description of the supplies/services to be purchased

- OPTON 31030. SW, BioPharma 4.1UPG FRM 2 All to All

- OPTON 31029. SW, BioPharma 4.1 Protien Analysis

- OPTON-31041. SW, PROTEOME DISCOVERER 2.5 (2-5 COPIES)

- OPTON-31043. SW, PROTEOME DISC 2.5 UPG FROM PREVIOUS

- OPTON-31055. SW, COMPOUND DISCOVERER 3.3

III. Identification of the statutory authority permitting other than full and open competition

☒ 41 USC 1901(e)(2) and FAR Part 13.106-1: Only one responsible source/Brand Name

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contractor(s) Thermo Electron North America LLC 5225 Verona Road Madison WI 53711

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs

This specific software is needed for the support and characterization of several current and future projects at the VRC/VPP, including Covid-19 (SARS-CoV2), universal influenza, and next generation mAbs. Currently, in the case of BioPharma Finder and Proteome Discoverer, a single copy of these software packages is located at VRC/VPP. This software purchase is to upgrade older software in lab and install additional copies of the software on other computers, standardizing software builds across the lab and enabling more users to parallel process data. These software packages are written by the instrument vendor (Thermo Electron) and has previously been integrated into the hardware and software infrastructure of VRC/VPP.

C. Describe why only the proposed contractor is capable of providing the requested supply/service

The lab currently contains Thermo insruments and software, allowing seamless processing of acquired data. Lab scientists use these software packages workflows and report generation done by this software. Any changes in software purchase would require learning new software and will result in significant downtime.

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