Global Life Sciences Solutions Preventative Maintenance Services
Closed Pre-Solicitation Posted
- Solicitation number
- 25-002333
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 811210 Electronic and Precision Equipment Repair and Maintenance
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Clinical Center, through its Office of Purchasing and Contracts, intends to award a sole-source, firm-fixed-price contract for preventative maintenance services for three Sepax Pro Cell Processing Systems used in cell therapy manufacturing and research. The contract will support the Department of Transfusion Medicine's Center for Cellular Engineering, with a critical objective of meeting FDA mandates for maintaining critical equipment used in drug product manufacturing, processing, and testing. Global Life Sciences Solutions USA LLC is the sole identified source for these services, as they are the exclusive provider of maintenance and software upgrades for their proprietary Cytiva equipment. The contract will be executed under FAR Part 13 Simplified Acquisition Procedures, which exempts the procurement from standard competition requirements. Interested parties capable of providing similar services may submit capability statements by December 28, 2024, at 12:00 pm EST to Sheri Eiri, with the government retaining sole discretion to determine whether to compete the proposed contract.
The pre-solicitation notice indicates no specific set-aside designation for this procurement, which falls under NAICS Code 811210 for Electronic and Precision Equipment Repair and Maintenance. The contract will be awarded exclusively to Global Life Sciences Solutions USA LLC, located in Marlborough, MA, with a performance period from January 27, 2025, to January 26, 2026. The scope includes preventative maintenance for three specific Sepax C Pro systems with serial numbers 29264741-8298-22-13, 29264741-8299-22-13, and 29264741-8300-22-13. While no specific award value is detailed, the procurement is being handled through simplified acquisition procedures, suggesting it is likely below the simplified acquisition threshold. The maintenance services are specifically tailored to support cell manufacturing research and development of cell-based therapies for patients enrolled in sponsored clinical trials, highlighting the specialized nature of the required services.
Notice text
Title: Global Life Sciences Solutions Preventative Maintenance Services
NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance (Small Business Size Standards $34M Average Annual Receipts)
PSC/FSC: J066 – Maintenance/repair/rebuild Of Equipment- Instruments and Laboratory Equipment
Place of Performance: National Institutes of Health, Clinical Center, Bethesda, MD 20892
POTS: 25-002333
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.
The National Institutes of Health, Clinical Center, Office of Purchasing and Contracts, on behalf of the Department of Transfusion Medicine, Center for Cellular Engineering intends to award a firm-fixed priced award to Global Life Sciences Solutions USA LLC located at 100 Results Way in Marlborough, MA 01752 on a sole source basis to perform preventative maintenance agreement for three (3) Sepax Pro Cell Processing Systems used in cell therapy manufacturing and research.
Period of Performance: 01/27/2025-01/26/2026
List of Equipment - Preventative Maintenance Services:
Sepax C Pro SN 29264741-8298-22-13 Quantity 1
Sepax C Pro SN 29264741-8299-22-13 Quantity 1
Sepax C Pro SN 29264741-8300-22-13 Quantity 1
The Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE) has a bona fide need for a preventive maintenance service contract for three (3) Sepax C Pro-Cell Processing Systems used in cell manufacturing research and development of cell-based therapies for patients enrolled in sponsored clinical trials. The Food and Drug Administration (FDA) mandates that critical equipment used in the manufacturing, processing, and testing of drug products must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67). This service agreement will fulfill this obligation for three (3) VIA Freeze Quad CRFs.
Global Life Sciences Solutions USA LLC is the sole service provider and the only vendor capable of performing the preventative maintenance services on the for three (3) Sepax C Pro-Cell Processing Systems. Global Life Sciences does not have any authorized third-party service providers or resellers or distributors of their equipment. Global Life Sciences is the only source with service technicians that are authorized to perform services on three (3) Sepax C Pro-Cell Processing Systems. Global Life Sciences is the only source capable of performing all software installations and upgrades as this is Global Life Sciences, Cytiva proprietary equipment. There are no other sources capable of meeting the government’s requirement in its entirety.
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:
Interested parties capable of providing the same or similar products or services described in this notice may submit a capability statement outlining their capability to perform the described work. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. The determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contract Specialist by email at sheri.eiri@nih.gov by the due date 12/28/2024 and time 12:00 pm EST marked in this notice.
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