Title of Project: Follow-up Qualification on Oncogenicity of 293F Cells Introduction. This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of qualified sources. Your responses to the information requested will assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS code for this Sources Sought Notice is 621511—Medical Laboratory Testing. Background. The Centers for Disease Control and Prevention (CDC) Influenza Division in the National Center for Immunization and Respiratory Diseases (NCIRD) are seeking to test the master cell bank (MCB) of Expi293F tm cells in further follow-up testing for tumorigenicity and oncogenicity. The CDC and NCIRD are responsible for the development of candidate vaccine viruses (CVVs) based on circulating and novel influenza strains. The CDC and FDA require good manufacturing practices (cGMP)-grade banks of cells to make products that can be used in pharmaceutical manufacturing and vaccine manufacturing, including influenza CVVs. cGMP cell banks are inherently stored as two banks per cell line, one Master Cell Bank (MCB) and one Working Cell Bank (WCB). The MCB is used to make the WCB, and the WCB is used in actual production workflows. According to current FDA guidance, both banks require significant characterization before use. Finally, once the qualified cell banks are produced, they must be maintained under cGMP cryostorage. The Virology Surveillance and Diagnostic Branch of the Influenza Division identified a new cell line, Expi293F™ cells, that significantly increases the success rate of CVV generation and enables egg-independent production of vaccines and influenza viruses. Purpose and Objectives. The overall objective is to test the Master Cell Bank (MCB) of Expi293F™ cells in further follow-up testing for tumorigenicity and oncogenicity. The Vaccine Preparedness Team of the Virology from the Virology Surveillance and Diagnosis Branch within the Influenza Division of the CDC shall be the principal scientific and technical party representing the government’s needs, working with an undetermined contractor from selected offerors. Representative batch sampling of the MCB lot will be sent to the contractor for regulated testing. Project Scope. The contractor shall provide 21CFR and cGLP-compliant in vivo oncogenicity testing via newborn nude mice per FDA guidance on the Expi293F™ MCB. The expected turnaround time (TAT) shall be 24 weeks. See a draft Statement of Work (SOW) attached to this announcement. Capability Statement/Information Sought. Page Limit: 10 PAGES. Interested firms are requested to submit a capability statement, which shall include documentation of the ability to perform the requirements and information on previous successfully completed contracts for the same type of work. The capability statement shall specifically address the criteria listed below ONLY. Please note that capability statements that only include marketing material will not be considered or reviewed. Your opinion about the difficulty and or feasibility of the potential requirement(s) or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; Your staff expertise, including your availability, experience, and formal and other training; include a discussion on your proven track record for the type of work as per the SOW; Your current in-house capability and capacity to perform the work; specifically, describe your experience conducting systematic literature reviews and meta-analyses of randomized clinical trial and immunogenicity study data. Principal investigators are expected to have published studies relevant to the proposed work in peer-reviewed scientific journals. The contractor should have experience establishing data use agreements with vaccine manufacturers and study investigators to share unpublished data relevant to the proposed work. Finally, project leads must have experience in statistical and analytic methods required for the proposed work.Completed projects in the last 5 years of similar size and scope; Corporate experience and management capability; Provide any examples of prior completed government contracts, references, and other related information; Recommendations for a different NAICS code. If so, please explain. Information Submission Instructions: Please include a cover page with the following business information. The cover page does not count against the page limit for the capability statement. Company name and address; UEI number and CAGE Code, as registered in the System for Award Management (SAM) at http://www.SAM.gov/; Do you have a government-approved accounting system? If so, please identify the agency that approved this system; Business Size and Type of Business (e. g., small business, 8(a), woman owned, veteran owned, etc.). Technical point of contact, including name, title, address, telephone number, and email address of the individual(s) who can verify the demonstrated capabilities identified in the response; Contracts’ point of contact, including name, title, address, telephone number, and email address; In your opinion, can this work fit under a GSA schedule? If so, which GSA schedule? Please provide the schedule number. Page Limitation : Capability Statements shall be limited to TEN (10) single-spaced pages, not including the cover page. Pages shall be formatted as follows: MS Word, 8 ½ x 11, 12 pitch, Times New Roman font with one (1) inch margins. Response Due Date : Submit capability statements via email to Dawnnia Daley, Contract Specialist, at
[email protected]. Should you have any questions concerning this source sought, please direct your questions in writing to the Contracting Specialist, Dawnnia Daley, at
[email protected] . The government will not respond to oral questions. Responses must be submitted no later than 11:59 pm, Eastern Standard Time (EST) by Sunday, August 25, 2024 . Capability statements will NOT be accepted after the due date. No telephonic or facsimile responses will be accepted. The government will not provide feedback on capability statements, and we will not return capability statements received. 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 on 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). Response is strictly voluntary . It is not mandatory to submit a response to this notice to participate in any formal RFP process that may take place in the future. However, it should be noted that information gathered through this notice may significantly influence our acquisition strategy. All interested parties will be required to respond separately to any solicitations posted as a result of this Sources Sought notice. We appreciate your interest and thank you in advance for responding to the sources sought.