Takara Bio USA – RetroNectin® GMP Grade Reagents
Closed Pre-Solicitation Posted
- Solicitation number
- 26-005759
- Agency
- Office of Logisitics and Acquisition Operations National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
-
- Shasheshe Goolsby shasheshe.goolsby@nih.gov (301) 827-4879
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Clinical Center intends to award a sole-source, firm-fixed-price contract to Takara Bio USA Inc. for RetroNectin GMP grade reagents by May 14, 2026. No competitive solicitation will be issued; this pre-solicitation notice is informational only and does not constitute a request for quotations.
The procurement covers 15 vials of RetroNectin GMP grade reagent (Product Code: T202), which support cellular therapy manufacturing within the Center for Cellular Engineering. Work is performed at the NIH Clinical Center in Bethesda, Maryland. Takara Bio USA Inc. is the sole manufacturer of RetroNectin GMP grade reagent; substitution would require revalidation and regulatory approval, which could delay treatment and pose risks to patient care. The CCE currently supports more than 50 intramural clinical trials and manufactures cellular therapy products for patient care.
The acquisition is conducted under FAR 13.106-1(b)(1) for single-source procurement when only one source is reasonably available. Simplified Acquisition Procedures under FAR Part 13 exempt this action from competition requirements of FAR Part 6. Although no quotations are solicited, interested parties may submit capability statements demonstrating ability to meet the requirement; responses must include company name and address and technical capability.
Notice text
Title:
Takara Bio USA – RetroNectin® GMP Grade Reagents
Product Service Code (PSC): 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
NAICS Code: 325413 – In Vitro Diagnostic Substance Manufacturing
Place of Performance:
National Institutes of Health
Clinical Center
Bethesda, MD 20892
POTS: 26-005759
Description
This notice is issued for informational purposes only and does not constitute a request for quotations. A solicitation will not be issued, and quotations will not be requested.
The National Institutes of Health (NIH), Clinical Center, intends to award a sole source firm-fixed-price contract to Takara Bio USA Inc. for the procurement of RetroNectin® GMP grade reagents.
The requirement consists of 15 vials of RetroNectin® GMP grade reagent (Product Code: T202), which are critical for the manufacturing of cellular therapy products within the Center for Cellular Engineering (CCE).
Background
The Center for Cellular Engineering (CCE) supports over 50 intramural clinical trials and manufactures cellular therapy products used in patient care.
Rationale:
Takara Bio USA Inc. is the sole manufacturer of RetroNectin® GMP grade reagent. Substitution is not permissible without revalidation and regulatory approval, which could delay treatment and pose risks to patient care
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 it is determined that only one source is reasonably available to meet the Government’s requirements.
Acquisitions conducted under FAR Part 13 – Simplified Acquisition Procedures are exempt from the competition requirements of FAR Part 6.
Responses
This is not a request for quotations. However, interested parties may submit a capability statement demonstrating their ability to meet the Government’s requirement.
Responses must include:
- Company name and address
- Technical capability
- Proof of OEM authorization
- Relevant past performance
The Government will evaluate capability statements received in response to this notice. The determination not to compete this requirement is solely within the discretion of the Government.
Submission Instructions
Responses referencing POTS: 26-005759 must be submitted electronically no later than May 14, 2026, at 8:00 AM EST to:
Shasheshe Goolsby
Team Leader
Hospital and Laboratory Support Division
Office of Acquisitions and Logistics Management
National Institutes of Health
Email: shasheshe.goolsby@nih.gov
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