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MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biological Evaluation and R... MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biological Evaluation and Research (CBER) requirement for cryopreservation of two cell lines. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. 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- 541990 – All Other Professional, Scientific and Technical Services; the applicable Small Business Size Standard is $19.5 million. Statement of Work: Expansion, vialing and storage of clonal simian retrovirus infected cell line Part I: General Information A. Introduction/background Our lab has developed cell lines that are stably infected with simian retrovirus and produce different levels of viral RNA. Currently we need large scale production and cryopreservation of two of these cell lines as virus reagents. B. Scope The company will expand, vial at specified viable cell concentration, and cryopreserve the cell lines in liquid nitrogen. They will also perform quality check of the cells by sterility and mycoplasma testing. The vendor will also provide documentation of the protocols and certificates of analysis and a final report. The cells will be stored by the contractor for one-year. Part II: Work Requirements A. Technical Requirements Preparation and quality control (QC) of 250 vials (at 4 x 106 cells/vial) of two different adherent cell lines infected with a retrovirus. The vials of the clonal cell lines to be used for expansion will be provided in dry ice to the contractor within 30 calendar days after award. The contractor shall store the cells at a temperature equal or lower than -196 °C until they are ready to start the cell expansion. 1. Contractor shall prepare at least 250 vials with 4 x 106 cells/mL/vial for each cell line. Cell concentration is for live cells. a. Long-term storage, 2mL cryogenic Nalgene vials (or equivalent) shall be used for storing the cells. 2. Each cell line shall be expanded as follows: a. Grown in DMEM media supplemented 10% heat inactivated fetal bovine serum, 1mM Sodium Pyruvate, 2mM L-glutamine, 100 U of penicillin per mL, 100 µg of streptomycin per mL. i. FBS used for cell growth must be characterized (9 CFR 113.53 tested), heat inactivated and from non-BSE country of origin. The COAs should be provided upon completion of the contract. b. Incubation at 37 °C and 5% CO2 in a dedicated incubator. c. Cells shall be split when they reach 80-90% confluence in a biosafety cabinet to maintain sterile conditions. i. Details of cell passage shall be discussed prior to initiation of the work. d. Only one cell line shall be grown and cryopreserved at a time. Cells will be handled in a biosafety cabinet with at least one hour prior to any other cell line being used in the cabinet. e. Cells shall be grown in flasks of up to 225cm2. f. Composition of medium used for freezing the cells shall be discussed with the FDA prior to vialing and storage of the cells. g. Cells shall be pooled and maintained in a homogenous suspension for aliquoting and cryopreservation. h. The information for labeling the vials will be provided by FDA. 3. Records shall be provided for all biological raw materials used in cell line expansion and preparation of the final vialed product, including information on source/origin, any treatment (if applicable) and Certificate of Analysis (sera, trypsin, media and media components, etc). 4. Contractor shall keep detailed electronic records of the production and vialing of the cells and send to FDA at the completion of the work. Records must include details of cell passage (split ratio or cell counts) and include observation for health and confluence of the cells. Records need to be organized chronologically with dates and clearly readable. The report will also include a table of contents and a summary of the workflow. 5. Sterility testing, mycoplasma testing and viability check of the cryopreserved cell lines shall be performed at least two weeks after the cells have been frozen; the results of the sterility and mycoplasma test must be negative. A COA of each cell line shall be provided to the FDA. 6. Contractor shall provide the FDA principal investigator identified at time of award all timelines and updates during the production and testing of the cell lines; if any changes are required, the company shall discuss with investigator prior to proceeding. 7. Contractor shall provide demonstrated capability for long-term in-house storage of cell lines in liquid nitrogen temperature-controlled vessels at two locations to include detailed logs kept for production, testing, managing, orders, and shipping of biological materials. 8. Contractor shall send the FDA 20 frozen vials of each cell line at the end of production. Include all shipping charges FOB Destination for the shipment of the 20 vials of each cell line upon completion of production, and all shipping charges FOB Destination for additional shipments as required from cell lines stored at contractor’s facility. 9. Contractor shall transfer all the cryopreserved cell lines in liquid nitrogen to a specified repository in Maryland or Virginia within one year of vialing. Cost of transfer shall be included in the contract. B. Deliverables *Within 30 days of production completion for each cell line, twenty vials of each cell line meeting the minimum technical requirements set forth above shall be shipped on dry ice to the FDA principal investigator identified at time of award; * Detailed electronic report of the production and vialing of the cells. Report shall be provided containing production batch records, including details on the raw materials used for production (i.e., catalog number and lot numbers, for the serum, trypsin, etc), dates of passage, split ratio or cell counts, confluence and conditions of the cells during passage and the results of the sterility and mycoplasma testing. Records need to be organized chronologically with dates and clearly readable. The report will also include a table of contents and a summary of the workflow. *Certificate of Analysis shall be provided for each cell line. Deliverables should be shipped to: Name: to be completed at time of award Bldg 52/72, Room 1216 10903 New Hampshire Avenue Silver Spring, MD 20993 Tel: Email: Part III: Supporting Information A. Security -N/A- B. Place of Performance Cell line expansion and storage will be completed at the company site. Deliverables should be shipped to: Name: to be completed at time of award Bldg 52/72, Room 1238 10903 New Hampshire Avenue Silver Spring, MD 20993 Tel: Email: C. Period of Performance 12 months from the effective date of contract award. D. Special Considerations: These are non-severable biological/scientific services. FOB Point Destination. All items shall include shipping and handling to the destination identified herein. Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name, SAM Unique Entity ID 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 if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered products and services 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, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • Three (3) years of past performance service information, , where the respondent has provided same or substantially similar service solutions (cryopreservation and storage of virus cells lines) on the same or near-same brand name equipment. 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 (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 SAM Unique Entity ID number and size status) if not the respondent. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. • 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. • 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. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; • 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; and • Though this is not a request for quote, informational pricing is encouraged for both the purchase of the monitoring, gas and delivery. 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 May 31, 2024 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference CBER-2024-123503. 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 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).