Thermo Fisher Scientific (Life Technologies) Reagents and Consumable Materials for Cell Therapy Manufacturing

NOTICE OF INTENT TO SOLE SOURCE Thermo Fisher Scientific (Life Technologies) Reagents and Consumable Materials for Cell Therapy Manufacturing Agency Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center Program Office Center for Cellular Engineering (CCE), Department of Transfusion Medicine Notice Type Notice of Intent to Sole Source Proposed Source Thermo Fisher Scientific (Life Technologies) Response Due August 20, 2026 at 8:00 AM Eastern Time DESCRIPTION The National Institutes of Health (NIH), Clinical Center, Center for Cellular Engineering (CCE) intends to award a firm-fixed-price contract on a sole-source basis to Thermo Fisher Scientific (Life Technologies) for reagents and consumable materials used in the manufacture of cell-based therapies for patients enrolled in clinical trials at the NIH Clinical Center. REQUIRED MATERIALS Description/Part No./Quantity AIM V MED CTS 1000ML/0870112DK/12 Bottles DYNABEADS CD3/CD28 CTS 10 ML/40203D/3 Vials CTS AIM-V MEDIUM MINUS 1000ML/A3830801/12 Each ACK LYSING BUFFER 100ML/A1049201/20 Bottles RPMI 1640 100ML/11875101/25 Bottles CTS AIM-V MEDIUM MINUS 10L/A3830802/4 Each SOLE-SOURCE RATIONALE CCE manufactures cell-based therapies under FDA-regulated current Good Manufacturing Practice (cGMP) conditions. The required Thermo Fisher Scientific (Life Technologies) reagents and consumable materials have been validated for CCE's manufacturing processes and approved by the CCE Quality Assurance Department. Substitution of these materials would require extensive requalification and validation of manufacturing processes, resulting in additional cost, significant time delays, and potential delays to patient treatment. Thermo Fisher Scientific (Life Technologies) can provide the required materials and quantities in a timely manner with the supporting documentation necessary for use in an FDA-regulated manufacturing process. The Government intends to proceed under the authority cited in the supporting justification, 41 U.S.C. 3304(a)(1), for an acquisition available from only one responsible source where no other supplies will satisfy the agency's requirements. CAPABILITY STATEMENTS / RESPONSE INSTRUCTIONS This notice is not a request for competitive quotations. However, all responsible sources that believe they can satisfy the Government's requirement may submit a written capability statement demonstrating their ability to provide the exact required materials, quantities, and supporting documentation without causing revalidation of CCE's established manufacturing processes. Responses must contain sufficient technical information for the Government to determine whether the respondent can meet the requirement. Please reference number 26-008602 when submitting capability statements and submit them by the due date to shasheshe.goolsby@nih.gov. Responses are due no later than August 20, 2026 at 8:00 AM Eastern Time. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government. The Government will not reimburse respondents for costs associated with preparing or submitting a response. Interested parties should submit their capability statement through the point of contact identified in the SAM.gov notice. The response should reference this Notice of Intent and the Thermo Fisher Scientific (Life Technologies) CCE reagents and consumable materials requirement.