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Notice of Intent to Sole Source - Life Technologies Corporation

Awarded

NOI-CC-25-008722Federal

Contract Overview

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

AI Contract Overview

The National Institutes of Health's Center for Cellular Engineering has issued a notice of intent for a sole-source acquisition of specific materials and reagents, including AIM V MED CTS 1000ml, DYNABEADS CD3/CD28 CTS 10 ML, HEPES, and RPMI 1640 100ML, used in the manufacturing of cell-based therapies for patient care. These materials have been thoroughly validated and approved by the Center’s Quality Assurance Department to ensure compliance with manufacturing standards and desired therapeutic outcomes. While these materials are available from multiple vendors, only Life Technologies Corporation is currently approved for use in their manufacturing processes. Substituting another supplier would require extensive and costly requalification procedures, thus limiting procurement to a sole source. This procurement is conducted under the Federal Acquisition Regulation’s Simplified Acquisition Procedures, specifically FAR Part 13, which allows contracting from a single source for purchases below the simplified acquisition threshold when only one source is reasonably available. The notice emphasizes that this is not a solicitation, and no quotations will be requested. However, interested parties may submit their interest and capabilities for consideration, though the government retains sole discretion in the decision not to compete the procurement. Comments and inquiries are directed to the NIH Office of Purchasing and Contracts through the designated contract specialist prior to the announcement's closing date.

General Info

NIH sole-source acquisition from Life Technologies for validated cell therapy manufacturing materials under FAR Part 13.

Agency

Department Of Health And Human Services → National Institutes Of Health - Cc

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

Justification for Limited Competition for NIH Purchase Request T256338

justification-and-authorization

High

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseAwarded

PostedAug 27

special-notice

AwardedOct 28

Contract was awarded

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc

Contacts1 person available

OfficeBETHESDA, MD, 20892, USA

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc

Office AddressBETHESDA, MD, 20892, USA

Contacts

Chris Ryssa Nix

contact@example.gov

Full Description

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. This procurement is for AIM V MED CTS 1000ml, DYNABEADS CD3/CD28 CTS 10 ML, HEPES and RPMI 1640 100ML Center for Cellular Engineering (CCE) uses AIM V MED CTS 1000ml, DYNABEADS CD3/CD28 CTS 10 ML, HEPES and RPMI 1640 100ML, material and reagents for patient care responsibilities and these materials are used to manufacture cell-based therapies for patients. All materials have been validated in manufacturing processes to ensure they are of the appropriate quality and that they produce the desired results. In addition, all materials are approved by the Center for Cellular Engineering Quality Assurance Department. Although the material and reagents are available from several sources, only Life Technologies Corporation has been approved by the Center for Cellular Engineering Quality Assurance Department for use in manufacturing protocols. Substitution with another vendor/contractor would require requalification of processes to accommodate the changes, which will be both costly and time consuming for the government. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 - Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing this posting number, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Ryssa Nix, Contract Specialist via email to contact@example.gov by close date.