Cytiva Sefia S-2000 Cell Processing Instrument Preventative Maintenance Services

Cytiva Sefia S-2000 Cell Processing Instrument Preventative Maintenance Services

• NAICS Code: 811210
• Product Service Code: J066

Place of Performance: Bethesda, MD

The National Institutes of Health

Clinical Center

10 Center Drive

Building 10, Room TBD

Bethesda, MD 20892

POTS: 25-002311

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 sole source contract to Global Life Sciences Solutions USA LLC to provide preventive maintenance and unlimited service repair coverage on three (3) Sefia S-2000 Cell Processing System instruments which are used in cell therapy manufacturing and research.

Contractor:
Global Life Sciences
100 Results Way
Marlborough MA 01752

Cytiva Sefia S-2000 Cell Processing Instruments
Cytiva Sefia S-2000 Cell Processing Instrument Serial # 29285527-8096.4280.
Cytiva Sefia S-2000 Cell Processing Instrument Serial # 29285527-8059.3139.
Cytiva Sefia S-2000 Cell Processing Instrument Serial # 29285527-8058.3129.

The Department of Transfusion Medicine (DTM), Center for Cellular Engineering has a bona fide need for preventive maintenance service contracts for the Sefia S-2000 devices that will be used in manufacturing research and development of cell-based therapies for patients enrolled on National Institutes of Health sponsored clinical trials at the Clinical Center. The Food and Drug Administration 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). Global Life Sciences is the original equipment manufacturer and sole supplier of Cytiva equipment and the only vendor capable of performing preventative maintenance services on the three (3) cell processing instruments. All repairs and preventative maintenance services must be performed by a Global Life Science authorized service technician. Global Life Science does not have any authorized third-party service providers. If a third-party performs services on the instruments, it may violate any warranties and the original equipment manufacturer, Global Life Sciences cannot guarantee the integrity of the instruments.

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, sheri.eiri@mail.nih.gov by the due date and time of December 29, 2024, by 12:00 pm EST marked in this notice.