Miltenyi gentleMACS Octo Dissociators with Heating Units
Waiver type - Procurement: Nonavailability
Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/17/2023
Procurement Summary
The gentleMACS Octo Dissociator with Heating Units, is manufactured by Miltenyi Biotec in Germany, will be used to support the mission of the Innate Immunity and Pathogenesis Section (IIPS), Laboratory of Neurological Infections and Immunity (LNII), of the National Institute of Allergy and Infectious Diseases (NIAID). The IIPS is requesting the above referenced gentleMACS Octo Dissociator with Heaters, manufactured by Miltenyi for use in our long-standing clinical and research projects. The IIPS focuses their research on the innate immune response is rapidly engaged after virus infection and functions to limit virus replication and mobilize adaptive immune responses. Viruses have evolved diverse strategies to suppress this critical host response and facilitate virus dissemination. In part, virus pathogenesis is a function of both the quality of the innate response evoked and the evasion strategies encoded by the invading pathogen. Thus, understanding the mechanisms underpinning immune activation and virus evasion will lead to improved vaccine design and novel therapeutics for treatment of both infectious and inflammatory disease. This gentleMACS Octo Dissociator with Heaters unit is an isolation system that is required to provide flexibility to researchers for multi-tasking and would allow consistent and higher productivity, to keep up with increasing studies and workload. The gentleMACS Octo Dissociator with heaters offers full automation for tissue dissociation and is enabling the dissociation up to eight samples at a time, without cross contamination and meeting the labs requirements by providing the required performance in standardization of sample processing from tissue to single cell suspension with high yield and viability. It also integrates user-friendly connectivity features for maximum operator convenience and traceability, which significantly increases the efficiency and productivity of experimental tasks in the lab. This gentleMACS Octo Dissociator with Heaters is also required to dissociate cells from various organs such as spleen, lymph nodes, brain, kidney etc. and make a single cells suspension and purification for studying the function of specific immune cells population during inflammation, autoimmune disease or after cellular activation with various stimuli. The unique required specifications for this instrument are tubes that bear a unique rotor/stator system for the gentle and efficient tissue dissociation or homogenization and the gentleMACS Dissociators are the only known devices that in combination with the gentleMACS Tubes can be used to dissociate or homogenize various tissues in a closed system, and process multiple samples at once without cross contamination. The only source and instrument known to meet these specifications is the gentleMACS Octo Dissociator with Heating Unit, which is manufactured by Miltenyi Biotec in Germany.
Waiver Rationale Summary
Based on the above market research findings and results from the brand name or equal request for quotes RFQ-NIAID-23-2175130 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 Miltenyi Biotech. 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 gentleMACS Octo Dissociator with Heaters unit, manufactured by Miltenyi in Germany. Based on the findings detailed above, the gentleMACS Octo Dissociator with Heaters unit, manufactured by Miltenyi 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.
Yes
No
Consistent with Policy
LABORATORY EQUIPMENT AND SUPPLIES
334516 - Analytical Laboratory Instrument Manufacturing
08/04/2023
RFQ-NIAID-23-2175130
Post-solicitation
0 - 6 months
Individual Waiver
NATIONAL INSTITUTES OF HEALTH