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This Pre-Solicitation opportunity from Department Of Health And Human Services was posted on May 5, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Takara Bio USA – RetroNectin® GMP Grade Reagents

Closed
26-005759Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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New
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MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

2 days ago

DEADLINE

in 4 days

AI Contract Overview

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The National Institutes of Health, through its Clinical Center in Bethesda, Maryland, intends to award a sole-source, firm-fixed-price contract to Takara Bio USA Inc. for the procurement of 15 vials of RetroNectin® GMP grade reagent, product code T202, which is essential for the manufacturing of cellular therapy products used in over 50 intramural clinical trials conducted by the Center for Cellular Engineering. Takara Bio USA is the exclusive manufacturer of this reagent, and no suitable alternatives exist without extensive revalidation and regulatory approval, which could disrupt critical patient treatments. The acquisition is conducted under FAR 13.106-1(b)(1), which permits sole-source procurement when only one supplier can meet the government’s requirements, and falls under simplified acquisition procedures exempt from full competition. Although this notice is not a formal solicitation and does not invite quotations, interested parties may submit a capability statement by May 14, 2026, at 8:00 AM EST to demonstrate their ability to fulfill the requirement. Submissions must include company details, technical capability, proof of original equipment manufacturer authorization, and relevant past performance. The government will review all submissions but retains full discretion to proceed without competition. The contract will be managed under POTS 26-005759, classified under NAICS code 325413 for in vitro diagnostic substance manufacturing, and the reagents will be delivered for use at the NIH Clinical Center in Bethesda, Maryland. All responses must be emailed to Shasheshe Goolsby of the Hospital and Laboratory Support Division.

General Info

NIH awards sole source contract to Takara Bio for 15 vials of RetroNectin® GMP reagent.

Agency

Department Of Health And Human Services → National Institutes Of Health OlaoView Agency

NAICS

325413 - In-Vitro Diagnostic Substance ManufacturingView NAICS

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PhaseClosed
Posted

Presolicitation

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao
Contacts1 person available
OfficeBETHESDA, MD, 20892, USA
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health Olao
View Agency Profile
Office AddressBETHESDA, MD, 20892, USA
Contacts

Full Description

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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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