METABOLISM QUALIFIED CRYOPRESERVED HUMAN HEPATOCYTES

This is a Food and Drug Administration (FDA) Small Business Sources Sought Notice for Commercial Supplies. This is NOT a solicitation for proposals, proposal abstracts, or quotations.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition is 325414; Biological Product (except Diagnostic) Manufacturing, with a small business standard size of 1,250 employees. The Product Service Code (PSC) is 6505: Drugs and Biologicals.

Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code is still encouraged to submit a Capabilities Statement.

**QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE**

BACKGROUND

The United States Food and Drug Administration (FDA) has a mission to protect public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. In addition, FDA is responsible for facilitating innovations that make medicines more effective, safer, and more affordable. To accomplish these goals, FDA has stimulated advancement of regulatory science, which is defined as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA regulated products.” FDA’s vision is to facilitate the integration of new science into the process of evaluating the safety and efficacy of proposed and marketed products and to close the gap between scientific innovation and this process of drug review. To achieve this vision, we perform mission-critical research to develop and evaluate tools, standards, and approaches to assess the safety, efficacy, quality, and performance of drugs.

The Division of Applied Regulatory Science (DARS) is conducting a research project to examine the effect of female sex hormones on in vitro drug metabolism. DARS operates several labs that provide mission- critical research supporting review questions, translational science, and emerging public health issues for Center for Drug Evaluation and Research (CDER) and FDA. We develop and evaluate novel tools, standards, and approaches that increase the regulatory efficiency of developing and reviewing safe and effective CDER products. These operational supplies are essential for the continuance of these projects across our labs, and for continued preparedness to be able to respond to emergent public health issues when called upon.

OBJECTIVE

The supplier is to provide protocol(s) for the thawing, plating and culturing the hepatocytes. This is to include the media composition and source for all these stages for the hepatocytes. The supplier will provide up to a total of 24 vials of cryopreserved human hepatocytes from 4 different female donors. Additionally, thawing and incubation media is required for the hepatocyte cultures.

PROJECT REQUIREMENTS

The U.S. Food and Drug Administration (FDA), Office of Clinical Pharmacology (OCP), Division of Applied Regulatory Science (DARS), requires metabolism-qualified cryopreserved human hepatocytes and associated materials to support mission-critical regulatory science research.

TECHNICAL REQUIREMENT SUMMARY

Respondents shall demonstrate the ability to provide cryopreserved human hepatocytes that meet the following requirements:

DONOR REQUIREMENTS

• Four (4) single-donor lots (not pooled)
• Donor demographics:
  • One (1) donor aged 20–35 years
  • Three (3) donors aged 54–70 years
• Donors must be:
  • Of U.S. origin
  • Negative for HIV and Hepatitis B/C
  • With available CMV and EBV test results

CELL QUALITY REQUIREMENTS

• Minimum 5 million viable hepatocytes per vial
• Minimum ≥85% viability post-thaw
• Must be metabolism-qualified, including:
  • CYP1A2
  • CYP2B6
  • CYP2C9
  • CYP2C19
  • CYP2D6
  • CYP3A4
• Must be:
  • Plateable in multi-well plates (12-well format)
  • Functional for 4–5 days post-plating

DOCUMENTATION REQUIREMENTS

Each donor lot must include:

• Certificate of Analysis (CoA) or equivalent
• Donor information (as available):
  • Age, sex, race/ethnicity
  • Cause of death
  • Substance use history
  • Liver-related medical conditions
• Metabolism activity data
• Biosafety information

DELIVERABLES

The contractor shall provide:

• 24 total vials (6 vials per donor lot × 4 donors)
• Associated materials, including:
  • Thawing media
  • Incubation/culture media
  • Antibiotic mix (if applicable)
• Cryogenic shipping container (e.g., cryoshipper)

PROTOCOL REQUIREMENTS

The contractor shall provide protocol documentation (PDF format) prior to shipment, including:

• Thawing procedures
• Plating procedures
• Culture conditions
• Media composition and sourcing

SHIPPING & DELIVERY REQUIREMENTS

• Shipment must maintain product integrity using:
  • Dry ice or liquid nitrogen
• Delivery must occur:
  • Within 7 days of award
  • Monday–Friday, 9:00 AM – 3:00 PM (excluding federal holidays)
• Delivery location:

U.S. Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993

• Delivery must be coordinated in advance with the Government POC

PERIOD OF PERFORMANCE

The anticipated period of performance is six (6) months from date of award.

CAPABILITIES AND TECHNICAL EXPERIENCE

Provide a capability statement describing how your company would be able to meet the requirements.

BUSINESS STATUS

Please provide your business size status (e.g., small business, 8(a), HUBZone, etc.) and SAM.gov Unique Entity Identifier (UEI) number.

DISCLAIMER AND IMPORTANT NOTES

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Responses to the sources sought shall be no longer than 10 pages.