1 - Bill of Material.docx

Bill of Material for RFQ-NIAID-2122909 Brand Name or Equal Requirements for NanoAssemblr Ignite Instrument and accessories manufactured by Precision Nanosystems.

https://www.precisionnanosystems.com/platform-technologies/product-comparison/ignite

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52.211-6 Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

1. Instrument must have capabilities to encapsulate mRNA vaccine candidates with a lipid nanoparticle (LNP) formulation with high homogeneity, reproducibility, controllability, and scalability.

2. Instrument that utilizes advanced microfluidics technology in an automated system for optimization of nanoparticle formulations for genetic vaccines for further scale up to the clinic.

3. The instrument must yield outstanding reproducibility by removing batch-to-batch and user-to-user variability. Advanced microfluidics in an automated system removes batch-to-batch and user-to-user variability.

4. Scalable Technology that allows formulations to be rapidly scaled across the NanoAssemblr platform from 100 µL to 50 L.

5. Touchscreen interface that allows saved recipes and a single-use fluid path enables a streamlined workflow.

6. Streamlined workflow; that allows rapid production. Rapid Production that allows for Over 50 formulations can be completed in a day for rapid optimization with each run taking less than one minute.

7. Versatile formulations including lipid, polymer or hybrid nanoparticles carrying small molecules, peptides, or nucleic acids (and more) can be formulated on the Ignite; Particle sizes can be tuned with precise control over fluid flow rates.

8. amenable to scale up from lab scale all the way to GMP scale

9. Controlled Assembly: Particle sizes can be tuned with precise control over fluid flow rates.

10. Genvoy LNP formulation mix

11. Microfluidic Mixing: Self-assembly of nanoparticles with defined size and properties

12. In-Line Dilution: Reduce proportion of solvent to stabilize nanoparticles

13. Tangential Flow Filtration: Process nanoparticles into final drug product form

14. Sterile Filtration: Sterilize drug product

15. Dimensions must not exceed (WxDxH): 40 x 44 x 73 cm

16. Delivery time must be included on quote

17. Technical support/training on the use of the instrument will be provided by the FAS (Field Application Scientist) team during and after installation

Quoting Instructions:

All offers shall include:

• Must list and address all requirements and include an instrument brochure if quoting an equal instrument

· Quote must indicate the place of manufacture for each item quoted

• Unique Entity ID# from active sam.gov registration must be included on quote. NIH no longer used DUNS numbers.