Miltenyi gentleMACS Octo Dissociator with Heating Unit
Waiver type - Procurement: Nonavailability
Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/23/2023
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 RNA Viruses Section (RVS), Laboratory of Infectious Disease (LID), of the National Institute of Allergy and Infectious Diseases (NIAID). The RVS is requesting the above referenced gentleMACS Octo Dissociator with Heaters, manufactured by Miltenyi for use in our long-standing clinical and research projects. The RVS has been generating seed viruses for live viral vector vaccines for intranasal immunization against SARS-CoV-2. The requested equipment is a fully automated tissue dissociation/homogenization device capable of executing up to 8 samples at one time with multiple programs allow various types of tissues. The instrument is essential for viral isolation/titration and isolation of lymphoid cells from tissue samples obtained from on-going pre-clinical animal studies. We possess one unit of this equipment, however there is a high demand with increased pre-clinical studies for COVID vaccines and, therefore, another unit is needed. The RVS focuses their studies of molecular biology, immunobiology, and pathogenesis of the human respiratory pathogens respiratory syncytial virus (RSV), human parainfluenza virus (HPIV) serotypes 1, 2, and 3, and human metapneumovirus (HMPV). Studies involve infection in vitro of epithelial cells, macrophages, and other cell types and in vivo infection of experimental animals to elucidate the viral replicative cycle, interactions between viral and host components, the host response to infection, and mechanisms of pathogenesis. Development of live-attenuated RSV, HPIV3, and HMPV vaccine candidates Vaccine candidates are designed to contain well defined attenuating mutations and are generated from cDNA by “reverse genetics”. Candidates are evaluated preclinically in monolayer cell cultures, in vitro models of airway epithelium, rodents, and nonhuman primates. Evaluation of candidate live vaccines in clinical studies with clinical collaborators, as well as wild type viruses in adult volunteers Development of vaccine vectors based on HPIV and avian paramyxoviruses (APMVs) for use against highly pathogenic emerging viruses including SARS Coronavirus 2, avian influenza, and Ebola viruses.
Waiver Rationale Summary
Based on the above market research findings and results from the brand name or equal request for quotes RFQ-NIAID-23-2175016 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 Statesmanufactured 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 there are no domestic alternatives available.
Yes
No
Consistent with Policy
LABORATORY EQUIPMENT AND SUPPLIES
334516 - Analytical Laboratory Instrument Manufacturing
08/08/2023
RFQ-NIAID-23-2175016
Post-solicitation
0 - 6 months
Individual Waiver
NATIONAL INSTITUTES OF HEALTH