GMP Grade Human Interleukin-2 (IL-2) from ACROBiosystems Inc.view on SAM.gov

NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT Title: GMP Grade Human Interleukin-2 (IL-2) from ACROBiosystems Inc. Notice ID (POTS): 26-006951 Product Service Code (PSC): 6505 – Drugs and Biologicals NAICS Code: 325414 – Biological Product (except Diagnostic) Manufacturing Place of Performance: National Institutes of Health Clinical Center Bethesda, MD 20892 Description This Notice of Intent (NOI) is issued for informational purposes only and does not constitute a Request for Quotations (RFQ). The Government does not intend to solicit competitive quotations for this requirement. The National Institutes of Health (NIH), Clinical Center, Office of Acquisitions and Logistics Management (OALM), intends to award a sole source, firm-fixed-price purchase order to ACROBiosystems Inc., 1 Innovation Way, Suite 302, Newark, DE 19711, for the procurement of fifteen (15) vials of CytoPak GMP Human IL-2 Protein (Part Number: GMP-L02H14GB01), including shipping. The supplies support FDA-regulated cell and gene therapy manufacturing activities performed by the Center for Cellular Engineering (CCE). Background The Center for Cellular Engineering manufactures cell and gene therapies for NIH clinical trials. These FDA-regulated manufacturing processes require all components and materials to be validated to ensure product safety, quality, and consistency. The CytoPak GMP Human IL-2 Protein manufactured by ACROBiosystems has been validated for use in CCE's approved manufacturing processes. Substituting another manufacturer's product would require extensive process revalidation, resulting in significant cost and schedule impacts. During revalidation, patient treatment could be delayed, potentially causing disease progression that renders patients ineligible for clinical trials. Consequently, delaying this procurement would not be in the best interest of either the Government or the patients. Sole Source Rationale ACROBiosystems Inc. is the only known source capable of providing the validated CytoPak GMP Human IL-2 Protein required for NIH's approved manufacturing protocols. An alternate product would require complete manufacturing process revalidation, causing significant delays, increased costs, and interruption of patient treatment. Authority This acquisition is being conducted in accordance with FAR 13.106-1(b)(1), Soliciting from a Single Source. Under this authority, the Contracting Officer may solicit from a single source when only one source is reasonably available to satisfy the Government's requirements. Acquisitions conducted under FAR Part 13 are exempt from the competition requirements of FAR Part 6. Responses This is not a Request for Quotations. Interested parties may submit a capability statement demonstrating their ability to satisfy the Government's requirement. Responses should include: • Company name and address • Technical capability • Proof of OEM authorization, if applicable • Relevant past performance The Government will evaluate all capabi…