75N98026Q01226 - Requirements Document.pdf

REQUIREMENTS DOCUMENT

Promega Assay Reagents to Support Complement-ARIE Mechanistic Toxicology Research

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 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 human-relevant models such as 3D microphysiological systems, human tissue chips, and organoid models to understand the adverse effects of chemicals, drugs, and natural products and develop innovative solutions for translational toxicology research. These efforts include the Complement-ARIE research grant awarded to NCATS and NIEHS to explore NAM-based approaches for modeling toxicity-induced liver injury in humans.

2) Objectives:

The MTB seeks to advance pioneering research in the modeling of toxicity-induced liver injury with human 3D microphysiological systems. To complete this work, Promega assay reagents are needed to enable characterization of key toxicological endpoints, including cell viability, liver injury, liver function, oxidative stress, antioxidant responses, and cellular bioenergetics.

Thus, a range of Promega assay reagents utilizing sensitive chemiluminescence detection have been identified to complement cell painting and omics endpoints and provide integrated mechanistic data. 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 toxicity-induced liver injury).

3) Scope:

The specific tasks for this acquisition are for Promega to ship the assay reagents to NIEHS for use in 3D microphysiological system experiments supporting the Complement-ARIE research grant. The expected delivery date will be the end of September 2026. The shipment will be delivered to NIEHS in Rall Building 101 in labs E144-146.

4) Acceptance Criteria:

Acceptance will be demonstrated by the successful performance of the Promega assays in our NIEHS laboratory to measure cell viability, liver injury, liver function, oxidative stress, antioxidant responses, and cellular bioenergetics in 3D microphysiological systems.

5) Technical Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary materials, assay reagents, and associated supplies, not otherwise provided by the Government, as needed to perform the Statement of Work below. Specifically, the Contractor shall:

• Technical performance will be judged based on the successful delivery and performance of the specified Promega assays for assessment of cell viability, liver injury, liver function, oxidative stress, antioxidant responses, and cellular bioenergetics in support of 3D microphysiological system experiments.

Product Quantity Price CellTiter-Glo(R) Luminescent Cell Viability, 10 x 10ml 4 $TBD CellTiter-Glo(R) Luminescent Cell Viability, 10 x 100ml 1 $TBD LDH-Glo(TM) Cytotoxicity Assay, 50ml 10 $TBD Triglyceride-Glo(TM) Assay, 50ml 4 $TBD ROS-Glo(TM) H202 Assay, 50ml 2 $TBD Lactate-Glo(TM) Assay, 50ml 2 $TBD P450-Glo(TM) CYP3A4 Assay with Luciferin-IPA, 50ml 2 $TBD GSH-Glo(TM) Glutathione Assay, 50ml 1 $TBD

Total $TBD

6) Type of Order

• Firm-fixed price

7) Delivery Date

• September 25, 2026

8) Delivery Location

• 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) Deliverables

Deliverable Due Date Promega assay reagents Start of the Period of

Performance

10) Technical Acceptance

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

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

• Not applicable.

12) Travel Requirements (if applicable)

• No government employee travel will be required.