Project Information

Bid Title

GMP Grade Human Interleukin-2 (IL-2) from ACROBiosystems Inc.

Issuing Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Location

Maryland

Published Date

Jul 8, 2026

Closing Date

Jul 17, 2026

Government Level

Federal

Status

Closed

Ref. #

26-006951

Original Source

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Bid Documents

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Project Description

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GMP Grade Human Interleukin-2 (IL-2) from ACROBiosystems Inc.

Active

Contract Opportunity

Notice ID

26-006951

Related Notice

Department/Ind. Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub-tier

NATIONAL INSTITUTES OF HEALTH

Office

NATIONAL INSTITUTES OF HEALTH OLAO

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General Information

• Contract Opportunity Type: Presolicitation (Original)
• Original Published Date: Jul 08, 2026 07:04 am EDT
• Original Response Date: Jul 17, 2026 07:00 am EDT
• Inactive Policy: Manual
• Original Inactive Date: Jul 18, 2026
• Initiative:
  • None

Classification

• Original Set Aside:
• Product Service Code: 6505 - DRUGS AND BIOLOGICALS
• NAICS Code:
  • 325414 - Biological Product (except Diagnostic) Manufacturing
• Place of Performance:
  Bethesda , MD 20892
  USA

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

Attachments/Links

Contact Information

Contracting Office Address

• 6011 EXECUTIVE BLVD., SUITE 503L
• BETHESDA , MD 20892
• USA

Primary Point of Contact

• Shasheshe Goolsby
• shasheshe.goolsby@nih.gov
• Phone Number 3018274879

Secondary Point of Contact

History

• Jul 08, 2026 07:04 am EDTPresolicitation (Original)

Commodity Codes

• FSC 65Medical, Dental, and Veterinary Equipment and Supplies

• NAICS 325414Biological Product (except Diagnostic) Manufacturing

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