75N98026Q01230 - Requirements Document.pdf

REQUIREMENTS DOCUMENT

Fluigent - Microencapsulation Fluidics System

1) Background and Introduction

The Division of Translational Toxicology (DTT) has a mission to improve public health through development of data and knowledge that are translatable, predictive, and timely. The Mechanistic Toxicology Branch (MTB) within the DTT conducts laboratory research to identify human health hazards and understand environmental toxicity through hybrid basic and applied science approaches that include development of new approach methods (NAMs) for toxicology research.

The MTB is pioneering innovative toxicology research with advanced cell systems such as human tissue chips and 3D organoid models to understand the adverse effects of chemicals, drugs, and natural products and develop innovative solutions for translational toxicology research.

2) Objectives:

The MTB seeks to solve ongoing challenges in the scalable generation of 3D human organoid/spheroid models by exploring the potential of microencapsulation technology to bioengineer human tissue models that better reflect human physiology for translational toxicology research. A Fluigent Microencapsulation System has been identified as uniquely suited for our exploratory research needs to model toxicity-induced liver fibrosis with 3D microtissue models. This work is funded by an external NIH grant in collaboration with NCATS through a Complement-ARIE grant award to develop human-based microphysiological systems and test methods that better model human health (in this case, the initial work will focus on liver).

3) Scope:

The Contractor shall provide a Fluigent Microencapsulation Platform, in accordance with the obtained vendor quotation. The system shall include the required suite of integrated microfluidic modules to enable controlled mixing of liquid alginate with human cell suspensions and formation of droplets that generate eggshell-like alginate capsules around suspension cells. This technology will support the formation of three-dimensional

(3D) microtissues and organoids.

The Contractor shall also provide installation and training for the Fluigent system at the

NIEHS facility. Vendor representatives shall perform system setup and provide training to facilitate rapid onboarding and use of the technology. The system will operate independently of NIEHS information technology (IT) systems and will not require NIEHS IT support.

The computer and software components are expected to be delivered by the end of

September 2026. Full system installation and training are expected to be completed in Fall 2026, subject to vendor engineer scheduling availability. Work shall be performed at

NIEHS, Rall Building 101, Laboratories E144–146.

All travel associated with installation and training shall be provided and funded by the

Contractor under the applicable maintenance agreement.

4) Acceptance Criteria:

Acceptance shall be demonstrated by the successful formation of alginate-encapsulated human liver microtissues within the NIEHS laboratory using the delivered and installed system.

5) Type of Order

• Firm-fixed price

6) Delivery Date

• September 25, 2026

7) Place of Performance

• NIEHS Building 101, Room E145, RTP, NC 27709. The point of contact will be Dr. Jingli Liu (Contractor) with support from Dr. Jonathan Diaz and Dr. Stephen Ferguson (Group

Leader).

8) Deliverables

Deliverable Delivery Date

Fully functional Fluigent

Microencapsulation System.

Start of the Period of

Performance

9) Technical Acceptance

• NIEHS lab staff will verify functionality of the system and work with technical scientific support to confirm operational success.

10) Government-furnished property, information, or equipment (if applicable)

• Not applicable.

11) Travel Requirements (if applicable)

• No government employee travel will be required.