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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.

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?

Yes

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

07/31/2024

Procurement Instrument Identifier (PIID)

N/A

Solicitation ID

N/A

Procurement Stage

Pre-solicitation

Expected Maximum Duration of the Proposed Waiver

0 - 6 months

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH