GMP Grade Human Interleukin-2 (IL-2) from ACROBiosystems Inc.
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The National Institutes of Health, through its Clinical Center, intends to award a sole source firm-fixed-price purchase order to ACROBiosystems Inc. for fifteen vials of CytoPak GMP Human Interleukin-2 Protein, a critical biological component used in FDA-regulated cell and gene therapy manufacturing. The product is essential for ongoing clinical trials conducted by the Center for Cellular Engineering, where process validation and material consistency are mandatory to ensure patient safety and treatment efficacy. Substituting an alternative supplier would necessitate full revalidation of the manufacturing process, leading to significant delays, increased costs, and potential中断 of patient treatments that could result in eligibility loss for clinical trials. ACROBiosystems Inc. is the only known source capable of providing the validated formulation required by NIH’s approved protocols, justifying the use of a sole source procurement under FAR 13.106-1(b)(1). This acquisition falls under the category of Drugs and Biologicals with a NAICS code of 325414 and will be delivered to the NIH Clinical Center in Bethesda, Maryland. While this notice does not constitute a solicitation, interested parties may submit capability statements demonstrating their ability to meet the requirement by July 17, 2026, at 7:00 a.m. Eastern Time. The Government retains full discretion to accept or decline submissions and will not open the procurement to competition unless a capable alternative is identified that can match the existing validated product’s requirements without disrupting clinical operations.
General Info
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Place of Performance
Bethesda, MD, 20892, USASet-Aside
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Full Description
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 capability statements received. However, the determination not to compete this requirement remains solely within the Government's discretion.
Submission Instructions
Capability statements shall reference POTS 26-006951 and must be submitted electronically no later than July 17, 2026, at 7:00 a.m. Eastern Time (ET).
Shasheshe Goolsby
Team Leader
Hospital and Laboratory Support Division
Office of Acquisitions and Logistics Management
National Institutes of Health
Email: shasheshe.goolsby@nih.gov