75N98026Q01231 - Requirements Document.pdf

REQUIREMENTS DOCUMENT

Lonza – Cryopreserved Primary Human Hepatocytes

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 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 advance pioneering research in the modeling of toxicity-induced liver fibrosis with human 3D microphysiological systems. To complete this work, patient-derived cryopreserved primary human liver cells are needed to enable optimization of culture conditions and address sex differences. Thus, 30 vials of male and 30 vials of female human hepatocytes that have been recently pre-qualified for spheroid formation with discounted pricing from their original list price due to their time in storage have been identified uniquely from Lonza. 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 specific tasks for this acquisition are for Lonza to ship 60 vials of spheroid-qualified cryopreserved primary human liver cells to NIEHS in liquid nitrogen storage. The expected deliver 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 formation of spheroids within our NIEHS laboratory.

5) Technical Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, 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 formation of rounded spheroids from each of the 60 vials provided within spheroid-forming cell culture plates.

6) Type of Order

• Firm-fixed price

7) Delivery Date

• September 25, 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) Deliverables

Deliverable Delivery Date 60 vials of cryopreserved primary human liver cells proficient in forming spheroids.

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.