Single-use Microfluidic Cartridges for NanoAssembler™ Ignite™ System

This is a Sources Sought notice for domestically manufactured products only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. Per the Buy American Act and Executive Order 14005, the National Institutes of Allergy & Infectious Disease (NIAID) is seeking information for domestically manufactured products only, Per the requirements under the Buy American Act and requirements relating to Executive Order 14005 entitled: “Ensuring the Future is Made in All of America by All of America’s Workers”, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO)’s Digital Waiver Portal is required." Respondents must certify in capabilities statement that products are manufactured in the United States. 

The purpose of this notice is to obtain information regarding the availability and capability of all U.S manufactured products that are equal to the following product: 
Single-use Microfluidic Cartridges for 100% compatibility with the NanoAssembler™ Ignite™ GMP System.

Specifications: 
The Single-use Microfluidic Cartridges must meet the following requirements: 
•    Must be a 100% compatible microfluidic cartridge with the NanoAssembler™ Ignite™ instrument system. 
•    Must be equipped with same or equal  NxGen™ mixing technology for use on both the NanoAssembler™ Ignite™ and NanoAssembler™ Ignite+™ systems for nanoparticle formulation. Also, this technology consists of a unique mixing architecture that includes toroidal structures within the flow path to ensure steady and consistent mixing conditions. This minimizes process redevelopment and mitigates risk. 
•    Must be single-use microfluidic cartridges optimized for flow rates of up to 20 mL/min. 
Single use reduces the risk of cross-contamination during process development of LNP formulation.
•    Must have capability for two reagents from 2 inlets flow through a NxGen mixer. Optionally, dilution buffer from a third inlet may be introduced at the end of the mixer to enable in-line dilution.
•    Must provide non-turbulent flow conditions for particle formation ensure reproducible results for a wide range of nanoparticle types.
•    Must ensure that no priming or cleaning is required; cartridges are single use.
•    Must be compatible with a wide range of solvents to make a diverse array of nanomedicine formulations.
•    Must have an automated in-line dilution version to allow modeling of the processes that will be required for future GMP production of nanoparticles. This automated, in-line dilution simplifies LNP workflows, saving time while ensuring particle stability.
•    Must be a single mixer to reduce risk during scale-up while maintaining particle quality and reproducibility.
•    Must provide 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.
•    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) 
•    Must provide a closed-system environment: The single-use tubing kit enables connection to external vessels and a closed-system environment allowing optimization of manufacturing processes used during clinical development and minimizing risk.
Cartridge specs to be compatible with NanoAssemblr™ Blaze™ 500D  CAT # 1000461 Qty: 20
Dilution - None 
Dilution ratio - 1:1 – 4:1 (dependent on recipe flow rates) 
Flow rate - 4 – 115 mL/min 
Flow rate ratio (FRR) - 1:1 – 5:1 (dependent on recipe flow rates) 
Instrument - NanoAssemblr™ Blaze™, NanoAssemblr™ Blaze+™ 
Mixer - NxGen™ 500 
Usage - Single use 
Volume  - 20 mL – 10 L 
Cartridge Requirements: to be compatible with CAT # NIN0061 Qty: 8 
Ignite™ and Ignite+™ NxGen™ cartridges (pack of 100)
Compatibility - Ignite™ and Ignite+™ systems 
Volume (pre-dilution) - 1 - 20 mL on Ignite™ system and 1 - 60 mL on Ignite+™ system Inlets for reagents - 2
Capability Statement/Information Sought
All capable vendors should respond with a brief capability statement demonstrating an equal product that is manufactured in the United States by July 19, 2024, by 1:00 PM EST. 

Capabilities statement must also include the following information: 1) organization name, address, point of contact, email address, website address, telephone number, UE ID# with an active SAM.gov registration, and a tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of capability.

Submission Instructions 
Interested businesses who consider themselves qualified to provide an equal product that is manufactured in the United States for the above-listed product are invited to submit a response to this Sources Sought Notice by July 19, 2024, by 1:00 PM EST. All responses under this Sources Sought Notice must be emailed to directly to, Diana Rohlman, diana.rohlman@nih.gov with the Sources Sought ID# SS-NIAID-24-2224473 in email the subject line. 

Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).