MICROFLUIDIC CARTRIDGES
Waiver type - Procurement: Nonavailability
Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/06/2024
Procurement Summary
100% COMPATIBLE USE WITH NANOASSEMBLR IGNITE microfluidic cartridges must be equipped with mixing technology for use on both the NanoAssembler™ Ignite™ and NanoAssembler™ Ignite+™ systems for nanoparticle formulation for the process development of lipid nanoparticles (LNPs) .Non-turbulent flow conditions for particle formation ensure reproducible results for a wide range of nanoparticle types. Automated in-line dilution versions allow modeling of the processes that will be required for future GMP production of nanoparticles.• A single mixer reduces risk during scale-up while maintaining particle quality and reproducibility. These cartridges are specific to an instrument that require these specific cartridges listed to be from this manufactured by the requested manufacturer. These proprietary cartridges are equipped with NxGen™ mixing technology for use on both the NanoAssembler™ Ignite™ and NanoAssembler™ Ignite+™ systems for nanoparticle formulation. The NxGen™ technology consists of a unique mixing architecture that includes toroidal structures within the flow path to ensure steady and consistent mixing conditions. This helps in the effective transfer of critical process parameters (CPPs) while scaling up by using our NanoAssemblr™ family of formulation systems, all of which are equipped with the same advanced NxGen™ technology. This minimizes process redevelopment and mitigates risk. The NanoAssemblr™ Blaze™ cartridges and tubing kits are single-use, reducing the risk of cross-contamination during process development of LNP formulations. In-line dilution of cartridges automates a key process, while the tubing kit enables external vessel connections. In-line dilution: Automated, in-line dilution simplifies LNP workflows, saving time while ensuring particle stability. Scalable: Efficient technology transfer of key process parameters using NxGen™ technology during scale-up from preclinical development to clinical and commercial production, helping to ensure consistent critical quality attributes (CQAs). Flexible: NxGen™ 400 and NxGen™ 500 cartridges enable a range of flow rates from 4 – 115 mL/min using the same NxGen™ mixing architecture but in different dimensions, enabling flexibility for formulation-specific process parameters. Closed-system environment: The single-use tubing kit enables connection to external vessels and a closed-system environment on the NanoAssemblr™ Blaze+™ system, allowing optimization of manufacturing processes used during clinical development and minimizing risk.
Waiver Rationale Summary
(3) Conclusion: Based on the above market research findings and results from Sources sought solicitation SS-NIAID-24-2224473 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. Two companies responded to the Sources Sought solicitation both responses were for the foreign manufactured brand cartridges, no domestic offers 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 Single-use microfluidic cartridge, manufactured in Canada by Precision Nanosystems for the total cost of $63,400.00. e. Determination, based on the Findings, that the Proposed Action is Justified under the Applicable Statute or Regulation. Based on the findings detailed above, Single-use microfluidic cartridges 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, consistent with FAR 25.103(b)(2) that these items are non-available.
Yes
Yes
Consistent with Policy
LABORATORY EQUIPMENT AND SUPPLIES
334516 - Analytical Laboratory Instrument Manufacturing
07/31/2024
N/A
Pre-solicitation
0 - 6 months
Individual Waiver
NATIONAL INSTITUTES OF HEALTH