Sol_75N98026Q01145.pdf

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9000 Rockville Pike Bldg. 10 Room 8N110

National Institutes of Health OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05 Bethesda, MD 20892-7511

75N98026Q01145

NICHOLAS CAPOBIANCO

+10

000-000000 Naoya Uchida

20892

09/03/2026

09/14/2026 1500 ED

Multiple

Bethesda

MD

The purpose of this COMBINED SYNOPSIS /

SOLICITATION (COMPETITIVE) is to provide

NHLBI with Laboratory Equipment for

Generation and Analysis of Lipid

Nanoparticles to Develop In Vivo Gene

Therapy.

The following FAR clauses and Provisions are applicable to this award.

FAR 52.204-13 System for Award

Management Maintenance (Oct 2018);

FAR 52.204-18 Commercial and Government

Entity Code Maintenance (Aug 2020);

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Continued...

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NSN 7540-01-152-8067

75N98026Q01145

Investigations (Dec 2015).

FAR 52.212-4 Contract Terms and Conditions -In addition to all the applicable commercial

Products and Commercial Services (Nov 2023)

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE

COMBINED SYNOPSIS / SOLICITATION (COMPETITIVE)

Title: Laboratory Equipment for Generation and Analysis of Lipid Nanoparticles to Develop In Vivo Gene Therapy

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N98026Q01145. This solicitation is issued as a competitive combined synopsis/solicitation for commercial products or commercial services. The Government intends to award a contract or purchase order resulting from this solicitation using full and open competition.

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold.

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, seeks to award a firm-fixed-price purchase order to the responsible offeror whose proposal represents the best value to the Government.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, effective 03/13/2026.

(iv) The associated NAICS code is 334516 – Analytical Laboratory Instrument Manufacturing, and the small business size standard is 1,000 employees.

• This requirement is unrestricted.

(v) Description of Requirement:

The National Heart, Lung, and Blood Institute (NHLBI) requires the following commercially available laboratory equipment to support research on hematopoietic stem cell (HSC)-targeted lipid nanoparticle (LNP) gene delivery for the advancement of in vivo gene therapy.

Offerors shall provide equipment meeting or exceeding the salient characteristics below.

Item 1 – Ignite+ Upgrade Kit (Quantity: 1)

An upgrade kit that installs on an existing Ignite platform to enable higher-throughput LNP formulation sufficient for animal-scale production.

• Increases maximum working volume from 20 mL to 60 mL

• Increases maximum flow rate from 20 mL/min to 200 mL/min

• Dimensions (W x D x H): 38 x 34 x 38 cm (no change to instrument footprint after installation)

• Weight: 16.5 kg

• Power: 100–240 V AC, 50/60 Hz

• Environment: General benchtop

• Must be compatible with and installable on the Government's currently owned Ignite device

Item 2 – AKTA flux S Semi-Automated Tangential Flow Filtration (TFF) System (Quantity:

1)

A semi-automated TFF system for larger-scale purification of LNPs following formulation, to be used in conjunction with 0.22 μm sterile filtration.

• Dimensions (W x D x H): 40 x 45 x 55 cm

• Weight: 25 kg

• Power: 100–120 / 220–240 V AC, 50/60 Hz, 400 W

• Environment: Flat, stable benchtop with sufficient clearance for tubing and filter cartridge installation

Item 3 – VIA Freeze Duo Controlled Rate Freezer (Quantity: 1)

A liquid-nitrogen-free, conduction-cooling controlled-rate freezer for cryopreservation of human CD34+ HSCs and LNPs, supporting high-efficiency recovery of frozen cells and LNPs for downstream transplantation and injection into humanized mouse models.

• Dimensions (W x D x H): 44.6 x 38.3 x 61 cm (requires 93.7 cm vertical clearance with lid fully open)

• Weight: 40 kg

• Power: 120–240 V AC, 50/60 Hz, 350 W

• Ambient operating temperature: 5 °C to 30 °C

• Ethernet port for data logging and remote monitoring

Offerors proposing an "equal" product shall clearly identify the product by manufacturer, brand name, model, and part number, and shall furnish descriptive literature demonstrating compliance with each salient characteristic.

(vi) Delivery Location:

National Institutes of Health National Heart, Lung, and Blood Institute Attn: Dr. Naoya Uchida 9000 Rockville Pike, Bldg. 10, Room 8N110 Bethesda, MD 20892

Required delivery: As soon as possible after award. Offerors shall state proposed delivery date (in calendar days after receipt of order) in their quotation.

(vii) [Reserved]

(viii) FAR 52.204-7, System for Award Management, applies to this acquisition.

(ix) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition.

(x) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation represents the best value to the Government, price and other factors considered.

(b) Evaluation Factors:

1. Technical Capability — the extent to which the proposed products meet or exceed all salient characteristics identified in Section (v).

2. Past Performance — the offeror's record of timely delivery and product quality on comparable prior orders.

3. Delivery Schedule — the proposed delivery timeframe after award.

4. Price — total evaluated price, including shipping and handling.

Technical capability, past performance, and delivery schedule, when combined, are approximately equal to price. The Government reserves the right to make award without discussions.

(c) A written notice of award or acceptance of an offer, issued within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer before the expiration date.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) Additional contract requirements or terms and conditions: The Ignite+ Upgrade Kit must be installable on the Government's existing Ignite device. Offeror shall include any standard manufacturer's warranty and installation/operational documentation with delivery.

(xiii) The Defense Priorities and Allocations System (DPAS) is not applicable.

(xiv) Submission Requirements:

Responses must include sufficient information to demonstrate the offeror's capability to provide the required product. Quotes shall include, at a minimum:

• Unit and total price for each line item

• Shipping and handling costs

• Delivery timeframe (calendar days after award)

• Delivery terms

• F.O.B. point (destination preferred)

• Manufacturer, brand name, model, and part/catalog numbers

• Product/service description and descriptive literature demonstrating compliance with salient characteristics

• Standard commercial warranty terms

Additional evaluation considerations may include past performance, warranty, lifecycle cost, maintenance availability, and environmental or energy efficiency.

Responses must include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received no later than Monday, September 14, 2026, at 3:00 PM EDT, and must reference solicitation number 75N98026Q01145. Responses shall be submitted electronically to nicholas.capobianco@nih.gov.

(xv) Point of Contact:

Nicholas Capobianco Contracting Specialist National Institutes of Health Email:

nicholas.capobianco@nih.gov

Statement of Need (SON)

The Statement of Need is required for all product orders over $15,000. The statement describes the labs goals and how the purchase of the goods or services will advance those goals.

1. Project Title

Generation and analysis of lipid nanoparticles to develop in vivo gene therapy

2. Statement of Need and Objectives

Hematopoietic stem cell (HSC)-targeted gene therapy has been proven as a one-time cure for various genetic diseases, including sickle cell disease (SCD). However, all successful HSC gene therapy trials have required ex vivo HSC culture for lentiviral gene addition and CRISPR gene editing, which limits the application of gene therapy. Recently, systemic injection of lipid nanoparticles (LNPs) has been demonstrated for in vivo gene editing in the liver; however, tissue-specific gene delivery remains crucial for the development of in vivo HSC gene therapies. Therefore, we are developing an HSC-targeted gene delivery system using lentiviral vectors (LVs) and LNPs, which enables the advancement of in vivo HSC-targeted gene therapy. It would allow for a single-injection cure for SCD on a walk-in basis worldwide, including in low-resource countries. It is a significant topic in the field of gene therapy for researchers and drug companies.

The Ignite+ Upgrade Kit is required for animal research to develop in vivo gene therapy. This kid is installed on the current Ignite device to be upgraded to Ignite+, and the upgraded Ignite+ device enables larger-scale LNP formulation, sufficient for several mice per production and a large animal per a few productions. The animal experiments provide us with biodistribution data, including on-target and off-target delivery, as well as gene therapy efficacy and side effects.

The AKTA flux S is required for the larger-scale purification of LNPs. After LNP formulation with Ignite+ instrument, LNPs are purified using Tangential Flow Filtration (TFF), followed by 0.22 μm sterile filtration.

This AKTA flux S enables semi-automated TFF for large-scale LNP formulation.

The VIA Freeze Duo Controlled Rate Freezer is required to freeze human CD34+ HSCs and LNPs. This controlled-rate freezer enables high-efficiency recovery of cryopreserved cells and LNPs. Frozen human CD34+ HSCs are transplanted to generate humanized mouse models, and frozen LNPs are injected into the humanized mice.

This in vivo gene therapy is applicable not only to blood diseases but also to other organs, including the heart and lungs. Now, this ongoing research to develop in vivo gene therapy is one of the main focuses of NHLBI research, which was demonstrated by our Scientific Director, Dr. Richard Childs. This project is conducted by our branch, including Dr. Tisdale’s and Dr. Larochelle’s laboratories, along with the NHLBI non-human primate program. Therefore, our purchase request for this project directly impacts the advancement of research at the NHLBI.

3. Product Specifications/Features/Salient Characteristics

Ignite+ Upgrade Kit The Ignite+ Upgrade Kit upgrades the standard Ignite platform to handle higher throughputs (max volumes from 20 mL to 60 mL and max flow rates from 20 mL/min to 200 mL/min). It is installed on our current Ignite device.

Dimensions (W x D x H): 38 x 34 x 38 cm (The instrument size does not change after installation.)

Weight: 16.5 kg Power Requirements: 100-240 V AC, 50/60 Hz Environment: General benchtop environment

AKTA flux S The AKTA flux S is a semi-automated TFF system.

Dimensions (W x D x H): 40 cm x 45 cm x 55 cm Weight: 25 kg Power: 100-120/220-240 V AC, 50/60 Hz, 400 W Environment: A flat, stable benchtop surface and sufficient clearance for tubing and filter cartridge installation

VIA Freeze Duo Controlled Rate Freezer The VIA Freeze Duo Controlled Rate Freezer is a liquid-nitrogen-free conduction-cooling system for cryopreservation.

Dimensions (W x D x H): 44.6 cm x 38.3 cm x 61 cm Note: Requires 93.7 cm vertical clearance when the lid is fully open.

Weight: 40 kg Power: 120-240 V AC, 50/60 Hz, 350 W Environment: Ambient operating temperature between 5°C and 30°C. Ethernet port for data logging and remote monitoring.

4. Delivery Information and Location

Delivery Address is 9000 Rockville Pike, Bldg. 10, 8N110, Bethesda, MD 20892, USA.

Deliver ASAP After Award

5. Point of Contact and Contact Information

Title