SAM #26-005759

NIH Sole Source Procurement of Takara Bio USA RetroNectin® GMP Grade Reagents

The National Institutes of Health (NIH) Clinical Center is seeking to procure specialized reagents for cellular therapy manufacturing: - Government Buyer: - National Institutes of Health (NIH), Clinical Center - Office of Acquisitions and Logistics Management - OEM and Vendor: - Takara Bio USA Inc. (sole manufacturer and supplier) - Products Requested: - 15 vials of RetroNectin® GMP grade reagent - Product Code: T202 - Critical for manufacturing cellular therapy products in the Center for Cellular Engineering (CCE) - Unique/Notable Requirements: - Sole source procurement; only Takara Bio USA Inc. can supply this product - No substitutions allowed due to regulatory and revalidation requirements - Product is essential for clinical-grade cell therapy manufacturing - Place of Performance: - NIH Clinical Center, Bethesda, MD

Description

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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