FDA-SSN24-122109.pdf

Lyobeads Production System or Equal Sources Sought Notice

FDA‐SSN24-122109

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 sources sought announcement on behalf of the Center for Drug Evaluation and Research (CDER) in order to determine if there are existing small business sources capable of providing a Lyobeads Production System or Equal. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The appropriate NAICS code for the acquisition is 334516 – Analytical Laboratory Instrument Manufacturing; Small Business Size standards – 1,000 employees.

Background:

The FDA encourages the use of advanced manufacturing technologies for pharmaceuticals, as these technologies have the potential to improve the reliability and robustness of the manufacturing process and supply chain. This increases timely access to quality medicines for the American public.

Lyobeads are an emerging advanced technology for improving the storage stability of moisture labile vaccines, biologics, and diagnostics.

To this end, the CDER, Office of Pharmaceutical Quality Research (OPQR), requires a Lyobeads production unit for manufacturing of frozen beads to support internal research in advancing adoption of emerging manufacturing technologies. The Lyobeads production system should be a reliable automated micro-dispensing unit and shall include all associated accessories for production of frozen spherical beads.

This requirement is a Brand Name or Equal configuration:

- Millrock Technology, Lyobeads Production System, part # BeadLab 10K, 1 - Each

Minimum Technical Requirements:

1. Shall be fully automated micro dispensing unit.

2. Shall be capable of producing customizable beads with specific volume of material.

3. Shall be capable of accurately dispensing volumes as low as 4 microliters with high repeatability.

4. Shall have a dispensing precision of 3% or less.

5. Shall accurately dispense 5 – 30 microliters of formulation as a single drop.

6. Shall rapidly freeze dispensed liquid formulation.

7. Shall have a holding tray or appropriate bead holder designed to reduce sticking of frozen beads,

8. Shall include a holding tray or appropriate bead container compatible with most laboratory scale dryers and ease transfer of beads to lyophilizer.

9. The design of the lyobeads production system shall reduce exposure of operator to liquid nitrogen.

10. Shall include vacuum sealable tray or bead tray.

11. Shall be capable of producing at least 10000 beads per hour.

12. Shall allow in-process tuning of bead volume and shape.

13. Shall have multiple printing modes.

14. Shall be easily scalable.

15. Shall yield beads with high consistency in shape and size accuracy of 2%.

16. Shall have a pause and resume dispensing functionality.

17. Shall provide associated factory acceptance test (FAT) and site acceptance test (SAT) documentation after installation.

18. Shall include dewars or appropriate accessory for filling and monitoring nitrogen levels.

19. Shall include all associated accessories required for safe operation and transfer of beads to lyophilizer.

20. Shall include all hardware and software if any required for operation of the bead production unit.

21. Warranty: Shall have a warranty, including parts and labor, for at least one year.

22. Delivery, Installation, and On-site training: The vendor shall cover all costs associated with system crating, shipping, and delivery. The vendor shall verify proper system operation via on-site performance testing including hardware and software configuration with existing instrument and software. The vendor shall provide on-site training for at least 6 scientists.

The system shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, software, and that otherwise required to meet these specifications, the FDA’s stated need and shall be fit for intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

Anticipated Delivery:

FOB Destination: Shipping, handling in-side delivery, installation, and training shall be not later than 90 calendar days after receipt of contract award.

Place of Delivery:

U. S. FDA – Center for Drug Evaluation and Research TPOC: To be provided at time of award WO Campus 10903 New Hampshire Ave.

Bldg. 64, Rm.1075 Silver Spring, MD 20993

Responses to this sources sought shall unequivocally demonstrate the respondent is regularly providing Lyobeads Production System or Equal. 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, SAM UEI 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/performance requirements identified above, to include descriptive material, literature, brochures, and other information.

3. Past Performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar instrument solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, dollar value, client name, client address, client 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 company (to include the firm’s SAM Unique Entity Identifier (UEI) 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.

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 is being requested.

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 July 29, 2024, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA‐SSN24-122109.

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.