FDA-SSN-1242528.pdf

UniverCells Bioreactor Consumables Sources Sought Notice

FDA-SSN- 1242528

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 Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing Bioreactor Consumables. 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 associated North American Industry Classification System (NAICS) code is 334516 – Analytical Laboratory Instrument Manufacturing; Small Business Size standards – 1,000 employees.

Background:

The Center for Biologics Research and Review (CBER), Office of Compliance and Biologics Quality (OCBQ), Division of Biological Standards and Quality Control (DBSQC) requires consumables for Univercells scale-X carbo bioreactor.

This requirement is as Brand Name or Equal configuration:

1. Univercells, scale-X carbo Bioreactor assembly, 10m², autoclavable, part # 02002777, 6 - Each

2. Univercells, scale-X carbo Bioreactor assembly, 30m², autoclavable, part # 02002779, 4 - Each

3. Univercells, scale-X carbo Manifold kit,10m², autoclavable, part # 02002778, 6 - Each

4. Univercells, scale-X carbo Manifold kit,30m², autoclavable, part # 02004245, 4 - Each

Minimum Technical Requirements

1. Shall be compatible with Univercells Scale X-carbo system.

2. Shall include a single-use autoclavable structured fixed-bed bioreactor offering 10m² or 30m² cell growth surface with pre-fitted manifolds and 8 fixed-bed sampling ports

3. Shall include single-use autoclavable manifold kit for cell culture and viral production in the scale-X carbo bioreactor 10m² or 30m².

4. The scale-X carbo manifold kit includes the following fluid handling kits:

a. 1 x Inoculation manifold

b. 1 x Base manifold

c. 1 x Harvest manifold

d. 1 x Foam trap manifold

e. 1 x Recirculation manifold

f. A kit of single-use bottles compatible with each manifold.

5. The consumables system shall be warranted for at less 12 months from the date of formal government acceptance.

Delivery/ Period of Performance:

FOB Point Destination. Shipping, handling, installation qualifications shall be no later than 60 calendar days after receipt of contract award.

Place of Delivery/Performance:

U. S. FDA - CBER

ATTN: To be provided at contract award

10903 New Hampshire Avenue Building 52/72, Room G364 Silver Spring, MD 20993

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered product/services meet the technical requirements identified above. 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. Sufficient descriptive literature that unequivocally demonstrates that offered products can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

3. Past Performance information shall include recent (within the last 3 years) and relevant (prior experience 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 (Bioreactor Consumables) 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. Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

6. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

7. Standard commercial warranty and payment terms.

8. 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.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before June 14, 2021 by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and Reference: FDA-SSN-1242528.

Notice of Intent:

Responses to this sources 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.

mailto:jennifer.johnson3@fda.hhs.gov

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 beta.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).