SOW.pdf

STATEMENT OF WORK

CDER-OTS-25-C-1539: OTS/OCP/DARS: Purchase of two (2) Emulate Zoe CM1 and one (1) Orb Hub Module-1 Organ-On-A-Chip culture modules.

1. BACKGROUND

The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is conducting a research program to evaluate the usefulness of microphysiological systems (MPS). MPS or organs-on-a-chip have been identified as a potential alternative to traditional in-vitro models. MPS are designed to maintain cells in a 3D microenvironment and have been shown to better recapitulate the in-vivo physiological environment compared to traditional cell culture methods. Given their enhanced physiological relevance, MPS could have a potential role in pre-clinical pharmacokinetic and toxicology studies.

Emulate, a developer of MPS, has designed a liver MPS. This microfluidic system contains two channels composed of polydimethylsiloxane (PDMS) where hepatocytes can be seeded into the apical channel other cells found in the liver can be seeded in the basolateral channel. To culture cells on the chip, the Emulate Zoe and Orb need to be acquired. Currently, this hardware is in our labs as a loan and we would like to purchase it. This hardware regulates the flow of media through the chip and is required to grow the cells.

2. OBJECTIVES

The objective of the contract is to purchase two (2) Emulate Zoe CM1 and one (1) Orb Hub Organ-On-A- Chip culture modules systems. This equipment is already in our labs as a loan and we would like to purchase them. This equipment will provide the FDA with the required technology and maintenance support. The system will be used to support FDA scientist throughout FDA organizations. The system will enable scientific capabilities consistent with the mission of the Center for Drug Evaluation and Research

(CDER).

3. SCOPE

FDA is seeking to purchase two (2) Emulate Zoe CM1 and one (1) Orb Hub Organ-On-A-Chip culture modules for studying microphysiological systems. This equipment is already present in the lab on a loan and we would like to purchase it.

4. REQUIREMENTS

Requirements for Zoe and Orb systems:

• Orb Hub module is required to regulate pressure needed to maintain flow in MPS chips; it should be in a range from at least 0uL/h-1000uL/h with 1uL/h increments.

• Zoe modules are required to regulate the media flow within MPS chips at a specific rates; it should be in a range from at least 0uL/h-1000uL/h with 1uL/h increments.

• Zoe modules must perform a regulate cycle to help remove any potential bubbles in MPS chip.

• Zoe modules must maintain a liquid-liquid interface or an air-liquid interface within the chip.

Description Part/Product # Quantity Unit Cost Total Cost

Zoë Culture Module 1 (Zoë-CM1) 2

Orb Hub Module 1 (Orb-HM1) 1

5. DELIVERABLES / SPECIFIC TASKS

• The modules listed in the table above are already present in the lab as a loan. They will be purchased and remain in the current laboratory:

US Food and Drug Administration 10903 New Hampshire Ave, WO 64 Rm 2083 Silver Spring MD 20993 Attn: Bhavya Bhardwaj (Bhavya.Bhardwaj @fda.hhs.gov)

Vendor will contact the Project Officer: Bhavya Bhardwaj (Bhavya.Bhardwaj @fda.hhs.gov) /

(443) 942-7919 by phone or email with any questions or concerns.

6. GOVERNMENT FURNISHED EQUIPMENT (GFE)/ GOVERNMENT

FURNISHED INFORMATION (GFI)

• None required.

7. PLACE OF PERFORMANCE

FDA White Oak Campus US Food and Drug Administration 10903 New Hampshire Ave, WO 64 Rm 2083 Silver Spring MD 20993

8. PERIOD OF PERFORMANCE: 12 months from the date of award

9. INSPECTION AND ACCEPTANCE CRITERIA

The Government will review all reporting requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the COR. The contractor shall submit the reporting Requirements/Deliverables to the COR in accordance with the delivery schedule.

The COR will perform inspection and acceptance of materials and services provided in accordance with the criteria stated in Attachment 2, Quality Assurance Surveillance Plan, and established in the detailed requirements specifications. The Contractor shall implement necessary changes within 10 business days from the day of change notification.