FDA-SSN-1252684.pdf

Primary Human Hepatocytes and Media Sources Sought Notice

FDA-SSN- 1252684

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the National Center of Toxicological Research (NCTR) in order to determine if there are existing small business sources capable of providing Primary Human Hepatocytes and Media.

The appropriate NAICS code for the acquisition is 541714 – Research and Technology in Biotechnology; Small Business Size standards – 1,000 employees.

Background:

The FDA/NCTR, Division of Biochemical Toxicology (DBT) requires primary human hepatocytes and media. DBT generated a set of HepG2 based stable cell lines which individually expresses cytochrome P450 (CYP). Preliminary studies with these cell lines, demonstrated they were stable and useful for assessing metabolic associated drug induced liver toxicity. These cells will be used for studying the toxicity of several drugs (Antiarrhythmic and Antidiabetics, etc.)

which are metabolism-related and identify the responsible metabolic enzymes.

Primary human hepatocytes are considered the “gold standard” for in vitro liver toxicity test, metabolism evaluation and mechanistic study on drug-induced liver toxicity. Primary human hepatocytes will be purchased to use as a standard for the metabolism activity and toxicity detection for future studies using the HepG2-CYP expressed cell lines.

Statement of Work The primary human Hepatocytes will be cultured and exposed to the drugs of interest along with the HepG2-CYP cultures. The resulting metabolic profile will be compared between the standard and expressed cell lines. Should toxicity not be present in an expressed line, indicates the drug or it’s metabolites, would be an indication that the specific site is not responsive to that selected drug. If there is an indication of toxicity in the standard cell line, this would confirm there is a site on the full spectrum cell, to show the selected drug or its metabolite is toxic to the human Hepatocytes. The comparison of the standard (full spectrum) cells with the fourteen CYP expressed lines will help in locating additional sites of toxicity to help in the process of determine which additional sites needed to simultaneously express multiple CYPs for a more balanced metabolic nature.

Minimum Technical Requirements:

1. Shall be able to provide plateable cryopreserved primary human hepatocytes.

2. The hepatocytes shall be either male or female dependent upon availability at the time of purchase. Cannot be a pooled sample.

3. Shall provide donor demographics and cause of death to government technical point of contacts (TPOC) within 15 calendar days of after receipt of contract award. Death resulting from liver disease not acceptable.

4. Shall provide a total of thirty vials within 30 days, if necessary.

5. Each vial shall contain not less than 4 million cells.

6. Cells shall have a certified re-thaw viability >85%.

7. Cells shall have been pre-tested for long-term culture (>7 days), spheroid formation, and 96-well compatibility. Results shall be provided with quote.

8. Shall provide cryopreservation media with the cell shipment. It shall be validated/prequalified to provide guaranteed results.

9. Thirty vials of the appropriate cryopreservation media shall be provided with cells.

10. Shall provide validated/prequalified plating and maintenance medium.

Deliver/Period of Performance:

FOB Point Destination. Vendor shall provide hepatocyte donor information list to government TPOC within 15 calendar days after receipt of contract award. Shipping and handling shall be not later than 30 calendar days after receipt of government TPOC notification of which cells will be acquired.

Place of Delivery:

U. S. FDA – NCTR

3900 NCTR Road Bldg. 53B, Rm. 215 Jefferson, AR 72079

Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing Primary Human Hepatocytes and Media. Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address.

Provide this same information again if responding to provide a service offered by another firm.

2. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the minimum technical and performance requirements identified above.

3. Past Performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near same applications for Primary Human Hepatocytes and Media as set forth herein. For each past performance reference, include the date of sale/service, description of work, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent.

4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and

SINs that are applicable to this potential requirement are also requested.

5. If applicable, identification of Best in Class (BIC) contract information or other Government Wide or HHS Wide Contracts that the equipment/service is available on.

6. If a large business, provide if subcontracting opportunities exist for small business concerns.

7. Standard commercial warranty and payment terms.

8. Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

9. Though this is not a request for quote, informational pricing for the service would be helpful.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before March 16, 2022 by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA-SSN-1252684.

Notice of Intent:

Responses to this source sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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.

Confidentiality:

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern.