SOURCES SOUGHT NOTICE # FDA_SSN_1227188 for purified virus stock Posted Date: May 1, 2020 Response Date: May 15, 2020 by no later than 2:00 pm CDT Classification: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets NAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing 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 purified virus stock 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 325413 – In-Vitro Diagnostic Substance Manufacturing, Small Business Size Standards – 1,250 employees. Requirement and Background The U.S. Food and Drug Administration’s (FDA) Division of Viral Products (DVP) operates within the Center for Biologics Evaluation and Research (CBER) Office of Viral Vaccines Research and Review (OVRR); it’s activities include development of high-quality viral reference reagents for evaluating the sensitivity of various next-generation sequencing (NGS) platforms, which requires quantities of purified virus stocks such as Porcine Circovirus type 1, Epstein-Barr Virus (HHV-4) and Feline Leukemia Virus. These stocks are used in collaborative studies with other FDA labs and centers and outside organizations. The current requirement is for the preparation and characterization of purified virus stocks to provide well-defined reagents necessary to assess the ability of NGS for detection of different virus types. Additional characterization of the prepared virus stocks, including determination of the genome copy number by Droplet Digital Polymerase Chain Reaction (ddPCR) and the infectivity titer (e.g., TCID50) and sterility and mycoplasma testing is also required for each stock described below. Minimum Technical Requirements Preparation and quality control (QC) of 1,000 vials (≥0.5 ml aliquots each) of the following sucrose gradient purified virus stocks are required: Porcine circovirus type 1; Mammalian orthoreovirus, type 1, strain Lang; Epstein-Barr Virus (HHV-4), strain B95-8; Feline Leukemia Virus, strain KT-FeLV-UCD-1; Human coronavirus OC43 (Beta coronavirus 1). Quantity of each purified virus stock listed above shall meet the following minimum technical requirements: 1. 1000 vials of ≥0.5ml aliquots (meeting minimum titer and genome copy requirements per vial) for each virus stock shall be produced; 2. Each virus shall be grown to reach the required specifications using appropriate cell line, media and optimized conditions with rigorous handling to ensure absence of any cross-contamination; 3. Records shall be kept of all biological raw materials used in virus growth and preparation of the virus final stocks, including information on source/origin, any treatment (if applicable) and Certificate of Analysis (for cells, viruses, sera, trypsin, media and media components, etc) and retain aliquots of each lot in case further examination is needed after initial evaluation of the virus stocks by NGS. These should be provided to the FDA upon request; 4. Purification of virus particles shall include nuclease treatment to reduce cellular DNA and RNA and a sucrose density gradient/cushion based on the virus density; 5. After concentration and purification, the company shall provide for each virus a stock containing a minimum of ≥1x107 infectious titer per ml (e.g. TCID50 per mL or as applicable) and genome copy number of ≥1010 genome copies per mL quantified by digital droplet PCR (ddPCR), except for orthoreovirus which must have ≥109 genome copies per ml; 6. Virus stock should be aliquoted prior to freeze down in ≥ 0.5ml aliquots; 7. Contractor shall determine genome copy number using ddPCR and infectivity titer (e.g. TCID50) of the final vialed product, post-freeze; 8. Contractor shall provide Certificate of Analysis for each item produced and a formal report containing genome copy number, infectious titer, technical details and documentation employed for virus preparation, concentration, purification, and characterization assays. The report shall include information regarding the cell and virus lot numbers used for production and assays used for characterization, including the data for the infectivity titer and genome copy number determination; 9. Sterility testing and mycoplasma testing of the virus stocks shall be performed; stocks must be negative for mycoplasma and bacteria contamination; 10. Contractor shall provide the FDA principal investigator identified at time of award all timelines and updates during the production and testing of the virus stocks; if any changes are required, the company shall discuss with investigator prior to proceeding; 11. Contractor shall provide demonstrated capability for long-term in-house storage of the required virus stocks for 5 years in temperature-controlled vessels at two locations to include detailed logs kept for production, testing, managing, orders, and shipping of biological materials; 12. Include all shipping charges FOB Destination for a minimum of five (5) individual shipments of twenty vials of each virus upon completion of production, and all shipping charges FOB Destination for additional shipments as required from virus stock stored at contractor’s facility. Delivery Address U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 52/72 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Deliverables *Within 30 days of production completion for each virus stock, twenty vials of each virus stock meeting the minimum technical requirements set forth above shall be shipped on dry ice to the FDA principal investigator identified at time of award; *Report shall be provided containing production SOP’s, including details on the raw materials used for production (i.e., catalog number and lot numbers, for the cells, viruses, serum, trypsin) and details of the virus stock characterization assays with raw data on assay standardization and testing of the virus stocks; *Certificate of Analysis shall be provided for each virus stock. Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the purified virus stocks meeting the technical requirements set forth above. Although the target audience for this Notice are small businesses or small businesses capable of providing these stocks 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, 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 with the capability of providing virus stocks offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the production of purified virus stocks which the responding firm is regularly engaged in providing. Capability statements must provide sufficient information that demonstrates the virus stocks technical requirements and delivery time identified above can be met; Provide recent (within the last three (3) years) and relevant past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar virus stocks. 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 DUNS number and size status) if not the respondent. 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 if subcontracting opportunities 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. 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 May 12, 2020, 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 Federal Contract Opportunities (formerly FBO) at https://beta.sam.gov. 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).