Takara Bio USA – RetroNectin® GMP Grade Reagents
SOL #: 26-005759Pre-SolicitationSole Source
Overview
Buyer
Health And Human Services
National Institutes Of Health
NATIONAL INSTITUTES OF HEALTH OLAO
BETHESDA, MD, 20892, United States
Place of Performance
Bethesda, MD
NAICS
In-Vitro Diagnostic Substance Manufacturing (325413)
PSC
In Vitro Diagnostic Substances, Reagents, Test Kits And Sets (6550)
Set Aside
No set aside specified
Original Source
Timeline
1
Posted
May 5, 2026
2
Response Deadline
May 14, 2026, 12:00 PM
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institutes of Health (NIH), Clinical Center, intends to award a sole source firm-fixed-price contract to Takara Bio USA Inc. for RetroNectin® GMP grade reagents. This presolicitation notice is for informational purposes only, but interested parties may submit capability statements to demonstrate their ability to meet the requirement.
Opportunity Details
- Requirement: Procurement of 15 vials of RetroNectin® GMP grade reagent (Product Code: T202).
- Purpose: These reagents are critical for the manufacturing of cellular therapy products within the Center for Cellular Engineering (CCE). The CCE supports over 50 intramural clinical trials and manufactures cellular therapy products used in patient care.
- Rationale for Sole Source: Takara Bio USA Inc. is identified as 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), which permits soliciting from a single source when it is determined that only one source is reasonably available. Acquisitions under FAR Part 13 – Simplified Acquisition Procedures are exempt from the competition requirements of FAR Part 6.
Response Information
- Type: Presolicitation / Sole Source Intent (not a request for quotations).
- Set-Aside: None specified (sole source).
- Submission: Interested parties may submit a capability statement demonstrating their ability to meet the Government’s requirement.
- Required Content:
- Company name and address
- Technical capability
- Proof of OEM authorization
- Relevant past performance
- Evaluation: The Government will evaluate capability statements received. The determination not to compete this requirement is solely within the discretion of the Government.
- Submission Deadline: May 14, 2026, at 8:00 AM EST.
- Submission Method: Electronically, referencing POTS: 26-005759.
- Contact: Shasheshe Goolsby (shasheshe.goolsby@nih.gov).
Place of Performance
National Institutes of Health, Clinical Center, Bethesda, MD 20892.
People
Points of Contact
Shasheshe GoolsbyPRIMARY
Files
Files
No files attached to this opportunity
Versions
Version 1Viewing
Pre-Solicitation
Posted: May 5, 2026