Requirements Document.pdf

STATEMENT OF WORK

CDER-OTS-25-C-1687: Purchase of Human Cells and Cell Culture Reagents

1. BACKGROUND

Three labs in FDA’s Division of Applied Regulatory Science (DARS) OCP/OTS/CDER operate labs that utilize cell culture models to address mission-critical research supporting review questions, translational science, and emerging public health issues for CDER and FDA. These labs require human cells, and the cell culture reagents which are essential for their growth and maintenance in-vitro, to address drug safety, disposition and efficacy questions that inform on regulatory decisions and drug labeling. DARS additionally uses these cells to develop, evaluate, and standardize cell-based drug development tools to help move new science into the regulatory process and to ensure the collection of robust and reproducible data. The use of multiple human cell types enables DARS researchers to evaluate multiple organ systems. Specifically, mammary epithelial cells will be used to evaluate drug transfer into breast milk, small airway epithelial cells will be used to assess drug permeability in the lung, endothelial cells will be used to vascularize in-vitro cell cultures models so that they are more physiologically relevant, hepatocytes will be used to assess mechanisms of drug-induced liver injury, and peripheral blood mononuclear cells (PBMC) will be used for immunological studies. These studies are performed in response to emerging regulatory questions and provide critical information to FDA reviewers to allow them to make important regulatory decisions.

2. OBJECTIVES

The objective of the contract is to obtain the specific cell types necessary to evaluate drug safety, metabolism, and efficacy across different organ systems and to obtain specific cell culture reagents to sustain their growth in-vitro. These efforts will provide vital information to FDA regulators and fellow researchers and aligns with CDER’s research goal to “develop and improve scientific approaches that aid in developing new drugs or evaluating their pre-market safety and efficacy”.

3. SCOPE

FDA is seeking 4 different human cell types and specific reagents to successfully thaw cryopreserved cells and maintain them in in-vitro cell culture to support evaluation of drug safety, metabolism, and efficacy to support mission-critical research.

4. REQUIREMENTS

Human cells, all cell types:

• Shall have rigorous quality control provided by vendor to ensure performance and batch-to batch or lot-to-lot consistency.

• Shall meet vendor guaranteed minimums for the number of viable cells, cell purity, sterility, and performance.

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

• Shall be shipped cryopreserved and shipped on liquid nitrogen.

Cell culture reagents:

• Shall meet vendor guaranteed metrics for quality, sterility, and performance and be shipped at appropriate temperatures.

• Shall have a minimum shelf life of 6 months upon receipt.

5. DELIVERABLES / SPECIFIC TASKS

• The Contractor shall provide the following deliverables on May 26th, 2025 and August 25th, 2025, as outlined below.

• The Contractor shall contact Robyn Becker (robyn.becker@fda.hhs.gov) to confirm the required lot number for human cryopreserved PBMC prior to shipment.

Description Part/Product

Delivery week of May 26

Delivery week of August 25 2025

Total items shipped

HMEC – Human Mammary Epithelial Cells Lot # needed 23TL198518 cc-2551 10 0 10

HMEC – Human Mammary Epithelial Cells Lot # needed 23TL075056 cc-2551 10 0 10

MEGM™ Mammary Epithelial Cell Growth Medium BulletKit cc-3150 7 8 15

ReagentPack™ Subculture Reagents, 100 mL cc-5034 3 2 5

SAGM™ Small Airway Epithelial Cell Growth Medium BulletKit™

CC-3118 5 5 10

EGM -2 MV Microvascular Endothelial Cell Growth Medium-2 BulletKitTM

CC-3202

5 5 10

HMVEC-L – Human Lung Microvascular Endothelial Cells

CC-2527 8 0 8

Human hepatocytes (cryopreserved, plateeable and interaction qualified

HUCPi 8 0 8

Human Cryopreserved Hepatocyte Thawing Medium

MCHT50 5 3 8

Human Cryopreserved PBMC, 100 x 10^6 per vial; phenotyped; Lot # needed: TBD

CC-2703P 50 0 50

Total mailto:robyn.becker@fda.hhs.gov

• 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.

• Items will be delivered to:

US Food and Drug Administration

10903 New Hampshire Ave, WO 64 Rm 2014

Silver Spring MD 20993

Attn: Martha Garcia (martha.garcia@fda.hhs.gov)

Freight should be delivered to WO Bldg 62 Loading Dock, and then to WO64-2014

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

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 2061 and 2081

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

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.