SOW_042825.doc

STATEMENT OF WORK

CDER-OTS-25-C-1637: Purchase of Human Induced Pluripotent Stem Cell-Derived (hiPSC) Cells.

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.

MPS utilizes large quantities of human induced pluripotent stem cell-derived cells (hiPSC) including cardiomyocytes, neurons, astrocytes, and hepatocytes. The cells are used across multiple program areas. The experiments conducted support regulatory science research projects including drug safety and efficacy assessment.

2. OBJECTIVES

The objective of the contract is to obtain Human Induced Pluripotent Stem Cell-Derived Cells. These cells will provide the FDA with the required material to support MPS studies. The cells will enable scientific capabilities consistent with the mission of the Center for Drug Evaluation and Research (CDER).

3. SCOPE

FDA is seeking to purchase human induced pluripotent stem cell-derived (hiPSC)cells.

4. REQUIREMENTS

Requirements for Human Induced Pluripotent Stem Cell-Derived Cells:

· Shall have rigorous quality control provided by vendor to ensure performance and batch-to batch or lot-to-lot consistency. Specifically, a batch/lot specific certificate with MEA (microelectrode array) functionality (e.g., field potential duration and beat rate) and viability.

· Shall be tested for and pass mycoplasma and sterility assessment.

· Shall be terminally differentiated and as such cannot be propagated or expanded.

· Shall include a user’s guide describing, at a minimum, cell storage, handling, plating, and maintenance recommendations.

· Shall include, at a minimum, enough culture medium to thaw and reanimate cells following cryopreservation and maintain the cells in the laboratory for a minimum of 14 days.

· Shall be shipped cryopreserved.

The Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes (hiPSC-CMs) must:

· Shall have at a minimum ≥ 5,000,000 viable cells/vial of cardiomyocytes

· Shall have at a minimum > 95% cardiomyocyte purity based on positive cTNT (cardiac troponin T) assessment.

The Human Induced Pluripotent Stem Cell-Derived neurons (hiPSC-NCs) must:

· Shall have at a minimum ≥ 6,000,000 viable cells/vial of glutamatergic neurons

· Shall have at a minimum > 90% neuronal purity based on positive Tuj+/Nes- or ßIII tubulin+/Nes- assessment.

The Human Induced Pluripotent Stem Cell-Derived Astrocytes must:

· Shall have at a minimum ≥ 1,000,000 viable cells/vial of astrocytes

· Shall have at a minimum > 95% purity

The Human Induced Pluripotent Stem Cell-Derived Hepatocytes must:

· Shall have at a minimum ≥ 10,000,000 viable cells/vial of hepatocytes

· Shall have at a minimum > 95% hepatocyte purity

5. DELIVERABLES / SPECIFIC TASKS

· The Contractor shall provide the following cells:

· Cells will be shipped frozen with sufficient dry ice to prevent thawing during transit.

· All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate new, usable and acceptable condition to the address as shown below.

· The cells will be delivered to:

US Food and Drug Administration

10903 New Hampshire Ave, WO 64 Rm 2014 Silver Spring MD 20993

Attn: Bhavya Bhardwaj (Bhavya.Bhardwaj @fda.hhs.gov)

Freight should be delivered to WO Bldg 62 Loading Dock, and then to WO64-2014 Vendor will contact the Project Officer: Bhavya Bhardwaj (Bhavya.Bhardwaj @fda.hhs.gov) / (443) 942-7919 by phone or email to schedule delivery of the cells within 14 days of the award date.

Deliveries must be coordinated with the Project Officer prior to shipment. No deliveries will be accepted without prior authorization from the Project Officer.

5.1 TASK 1

· One (1) shipment of all items described in section 4.0

5.1 Task 1

6. Government Furnished Equipment (GFE)/ Government Furnished Information (GFI)

· NA

7. Place of Performance

FDA White Oak Campus

US Food and Drug Administration

10903 New Hampshire Ave, WO 64 Rm 2014 Silver Spring MD 20993

8. Period of Performance Period of Performance will be for One (1) year from date of award.

9. Inspection and Acceptance Criteria

ADVANCE \d6The 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.