U.S. FDA SOURCES SOUGHT NOTICE (SSN) Bench-top flow cytometer system SSN #: 75F40122R113106 Posted Date: July 22, 2022 Response Date: July 31, 2022 Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing; Small Business Size Standard: 1,000 employees MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the bench-top flow cytometer instrument system described below. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a Small Business Set-Aside is possible. The appropriate NAICS code for the acquisition is 334516 – Analytical Laboratory Instrument Manufacturing, Small Business Size Standard: 1,000 employees. Requirement and Background The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) includes the Tumor Vaccines and Biotechnology Branch (TVBB), which functions within the Division of Cellular and Gene Therapy (DCGT), and whose primary mission is to develop and promote technology for safe, effective, autologous T-cell cancer vaccines for the greater mission of improving public health here in the United States. TVBB has recently acquired a sophisticated CliniMACS Prodigy system for the purposes of producing patient-derived Chimeric Antigen Receptor T (CAR-T) cells, which can then be redirected against tumor antigens within the patient. The Prodigy system offers the ability to produce CAR-T cells with similar characteristics to those produced in more traditional manners (expensive GMP facilities or industry-sponsored clinical trials – both very costly and timely methods) in a closed system suitable for clinical use. An integral, critical component of the existing CliniMACS Prodigy system and part of the Branch’s ultimate goal of obtaining a closed, continuous CAR-T cancer vaccine manufacturing system is the MACSQuant Analyzer 16 (or equal) flow cytometer system. Critical to the science required within the TVBB, the MACSQuant system facilitates magnetic selection, isolation and enumeration of certain subtypes of human blood cells based on flow cytometric technology, which are used for manufacturing adoptive CAR-T cell cancer vaccines. This instrument will also play a vital role in the FDA’s ability to manage regulatory files with complex issues, i.e., along with the Prodigy system, it is required as part of a research-regulatory project developed to understand and make regulatory judgments on critical quality attributes of cancer vaccines It is anticipated that any solicitation issued subsequent to this Notice shall include the clause at FAR 52.211-6 Brand Name or Equal (Aug 1999). This requirement is for a MACSQuant Analyzer 16 (or equal) bench-top flow cytometer system that shall integrate seamlessly with an existing Miltenyi Biotec CliniMACS Prodigy system. Salient physical, functional, or performance characteristics that an “equal” bench-top flow cytometer system must meet are specified as follows and shall be identified by brand name and make/model/catalog number: *Shall be a fully functional, new, flow cytometer instrument system to include integrated software; *Shall seamlessly integrate with an existing CliniMACS Prodigy system; *Shall be “bench-top” size no larger than 28”W x 17”D x 23”H; *Shall be capable of magnetically isolating certain types of T cells; *Shall be capable of characterizing and enumerating T-cells through FACS analyses using validated human reagents; *Shall have a minimum of three lasers and 16 optical channels; *Shall be capable of phenotypic analysis with fluorescent antibodies and functional analysis of fluorescently-labeled cells; *Shall include sampler unit to process multiple samples; shall be compatible with 96-well plates to allow for multiplexed, high-throughput sample analysis; *Shall include reagent rack and tube cooling rack (for 24 x 5 mL tubes); *Shall include comprehensive on-site training and system familiarization for FDA personnel; *Shall include all shipping charges FOB Destination; *Shall include minimum 1-year full manufacturer’s warranty. Contract Type: Commercial Product-Firm Fixed Price Delivery Address: U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 52/72, Room 3126 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in supplying the MACSQuant Analyzer 16 (or equal) bench-top flow cytometer systems described herein. Although the target audience for this Notice are small businesses or small businesses capable of providing these types of instruments from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following: Business name and bio, SAM Unique Entity Identifier (UEI), 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 with the capability of providing these types of instruments offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the MACSQuant Analyzer 16 (or equal) bench-top flow cytometer systems the responding firm is regularly engaged in providing. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements identified above can be met; Provide recent (within the last three years) and relevant past performance information where the offeror has provided same or substantially similar instrument systems. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address and phone number, and e-mail address (if different from that provided for client); If applicable, standard commercial warranty and payment terms; If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN’s that are applicable to this potential requirement are also requested; If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns; Though this is not a request for quote, informational pricing is encouraged; The Government is not responsible for locating or securing any information, not identified in the response; Respondent shall advise if the services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract. If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required. Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on July 31, 2022 to Tim Walbert, Contract Specialist, at the following address:
[email protected]. Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether or not 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/or combined synopsis-solicitation may be published on SAM/Federal Contract Opportunities (formerly FBO) at https://sam.gov/content/opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality and Proprietary Information 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).