Acquisition of Services for the Production and Stability Testing of Clinical Grade Lentiviral Vector

BACKGROUND The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA) intends to procure services, on a sole source basis, from Vector Biomed, Inc., 910 Clopper RD STE 200S, Gaithersburg, Maryland 20878-1361. This notice is being publicized in accordance with Federal Acquisition Regulation (FAR) Subpart 5.2. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.501(a); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325414 and the business size standard is 1,250 employees. UNIQUE QUALIFICATIONS OF THE PROPOSED VENDOR This acquisition includes services for the production of purified, clinical grade lentiviral vector. Ultimately, this product will be used in a phase I clinical trial for adults with solid tumor malignancies. In this trial, genetically engineered myeloid cells (GEMys) will be examined for their ability to locally deliver anti-tumor factors to the tumor and metastatic microenvironment. For clinical development, infectious particle concentration (titer) is one of the most important product quality attributes of a lentiviral vector. The proposed source, Vector Biomed, utilizes a robust propriety system optimized to produce consistently high titer vector product. This system relies on the interplay of the molecular design of the vector construct, an optimized cell production process and an efficient purification and formulation process. Vector Biomed previously provided NCI/CCR/POB with research-grade lentiviral vector, as well as preclinical-grade lentiviral vector supernatant. To ensure continuity in service and scientific comparison of data previously obtained on the research grade and the preclinical grade lentiviral vector, POB requires the clinical grade vector to be produced using the same techniques, with the same production system, and the same transfer plasmid (IL12-GEMy). POB invested significant resources to confirm the successful, highly efficient transformation of patient myeloid cells with the resultant lentiviral product received from this vendor in time- and cost-extensive preclinical experiments. These products were extensively tested for their ability to transform myeloid cells into genetically engineered cells that promote anti-tumor immunity by successfully invading tumors to locally deliver interleukin-12. As the transfer plasmid design is proprietary and essential to the overall vector design platform, clinical vector manufacturing must be performed by Vector Biomed. An award to a different vendor would be detrimental to the integration of the new clinical data into POB's existing research data on this vector. A different vendor would be required to design a different transfer plasmid, which would in turn lead to a different product with untested myeloid cell transformation efficiency, thereby jeopardizing the conduct POB's studies. RESPONSE INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, it may submit a proposal/quote/capability statement for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. All responses must be sent via email to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov by no later than 3:00 PM EST, on Friday, July 19, 2024 (7/19/24). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, Contractors must be registered and have an active certification for - all awards in SAM.gov. Reference 75N91024Q00145 on all correspondence. Please see the attached sole source notice of intent document ("NOI_75N91024Q00145") for a full description of the requirements for this acquisition.