75N98026Q01255 - Requirements Document.pdf

REQUIREMENTS DOCUMENT ATTACHMENT 2

REQUIREMENTS DOCUMENT

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 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 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 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) Intended Application:

The system shall support a microfluidic process in which:

• A liquid alginate formulation is delivered under controlled conditions;

• A human-cell suspension is delivered under controlled conditions;

• The required fluid streams are combined using a controlled microfluidic process;

• Droplets containing the cell suspension and alginate are generated;

• The resulting droplets can be processed to form alginate capsules containing human cells;

and

• The encapsulated cells can subsequently be used in the development of 3D cellular models.

• The system shall be suitable for laboratory use with human cell suspensions and alginate-based formulations consistent with the manufacturer's operating parameters.

5) Technical Requirements:

5.1 Fluid Handling:

The system shall provide controlled delivery of the fluid streams required for the intended microencapsulation process.

The system shall provide independent control of the required fluid streams to permit adjustment of operating conditions used for droplet generation.

The fluid-handling system shall be suitable for use with alginate-containing solutions and human-cell suspensions.

The system shall provide sufficient control and reproducibility of fluid delivery to support consistent droplet formation under established operating conditions.

5.2 Microfluidic Droplet Generation:

The system shall include a microfluidic droplet-generation capability suitable for producing droplets containing alginate and human-cell suspensions.

The droplet-generation process shall be controllable through adjustment of applicable operating parameters.

The system shall be capable of producing droplets suitable for subsequent formation of alginate capsules containing human cells.

5.3 Cell Encapsulation:

The complete system shall support controlled encapsulation of human cells within an alginate-based matrix.

The system shall be capable of supporting formation of cell-containing alginate capsules under reproducible operating conditions.

The system shall be suitable for the Government's intended application involving development of 3D human cellular models.

5.4 System Integration and Control:

The system shall include the control hardware and software necessary to operate the fluid-handling and droplet-generation components.

The operator shall be able to configure and control the operating parameters necessary for the intended microencapsulation process.

All software required for normal operation of the delivered system shall be included in the quoted system configuration.

5.5 Computer:

If a dedicated computer is required for operation of the system, the Contractor shall provide the computer and all required peripherals.

The computer shall include all software necessary to operate the system.

The system shall be capable of operating independently of NIEHS enterprise IT infrastructure and shall not require connection to NIEHS enterprise networks for normal operation.

5.6 Microfluidic Modules and Accessories:

The Contractor shall provide all microfluidic modules, tubing, fittings, connectors, reservoirs, adapters, interfaces, and other accessories required for normal operation of the proposed system for the intended application.

Components necessary to connect and operate the fluid-handling and droplet-generation system shall be included in the quoted price.

6) Type of Order

• Firm-fixed price

7) Delivery Date

• September 30, 2026

8) 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).

9) Installation and Configuration

The Contractor shall deliver and install the complete system at the designated NIEHS facility.

• Installation shall include, as applicable:

• Assembly of system components;

• Connection and configuration of fluid-handling and microfluidic components;

• Installation and configuration of required software;

• Configuration of control equipment;

• Operational checkout; and

• Demonstration that the system is ready for laboratory use.

The Contractor shall provide all labor and equipment necessary to complete installation.

10) Training

The Contractor shall provide on-site training for designated NIEHS laboratory personnel following installation.

Training shall include, as applicable:

• System startup and shutdown;

• Normal system operation;

• Operation of the control software;

• Configuration of fluid-delivery parameters;

• Operation of the microfluidic droplet-generation components;

• Preparation and loading of process fluids;

• Procedures for generating alginate-containing droplets;

• Routine cleaning and maintenance;

• Basic troubleshooting; and

• Applicable safety and operating procedures.

Training shall be sufficient to enable designated laboratory personnel to independently perform routine operation of the system for the intended application.

11) Acceptance Criteria

The Government will evaluate the delivered system to determine whether it satisfies the requirements of this Requirements Document.

Acceptance shall require:

1. Delivery of the complete quoted system configuration;

2. Successful installation and configuration at the designated NIEHS facility;

3. Successful operation of the system's control hardware and software;

4. Demonstration of fluid-handling and droplet-generation functionality;

5. Completion of required on-site training; and

6. Demonstration that the system is capable of performing the intended microencapsulation process.

At the Government's discretion, acceptance testing may include demonstration of formation of alginate-encapsulated human-cell-containing droplets or microtissues using Government-provided materials.

Acceptance testing shall evaluate the capability of the delivered system and shall be conducted in accordance with the manufacturer's applicable operating procedures and the requirements of this document.

12) Warranty

The Offeror shall identify the warranty provided with the proposed system, including the duration and scope of warranty coverage. Any warranty limitations, exclusions, or additional maintenance requirements shall be identified in the quotation