Title: Global Life Sciences Sepax Cell Separation Kits

Title:  Global Life Sciences Sepax Cell Separation Kits  

NAICS Code:       325413-In Vitro Diagnostic Substance Manufacturing (1250 Average Number of Employees)
PSC/FSC:              6550-In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
Place of Performance:  National Institutes of Health, Clinical Center, Bethesda, MD 20892

POTS:  25-000667

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 (NIH), Office of Purchasing and Contracting on behalf of the Department of Transfusion Medicine, Center for Cellular Engineering Services intends to award a firm fixed price contract to Cytiva-Global Life Sciences Solutions USA LLC located in Marlborough, MA 01752-3078 on a sole source basis to supply Sepax Separation Kits and Fill Paque Premium.

Item Descriptions:
Line-Item: 0001
Description:  CS-900.2 Sepax cell separation kit - Box of 6 Units Quantity 4

Line-Item: 0002
Description: Ficoll Paque Premium 6X100ML Quantity 4

The Department of Transfusion Medicine, Center for Cellular Engineering Services manufactures cell-based therapies for patients who either have no or have exhausted all other standard treatment options.  The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the Food and Drug Administration (FDA) in 21 CFR 210, 211, 600 and 1271.  The Food and Drug Administration mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67).

The Department of Transfusion Medicine has a need for four (4) cases of CS-900.2 Sepax Cell Separation kits and four (4) cases of Ficoll Paque Premium reagents used in support of patient care.  The reagents are compatible with the government owned Sepax C-Pro Cell Processing Instruments.  The Sepax C-Pro Cell Processing System is used with reagents in the cell production process of isolating lymphocytes from whole blood.  These reagents are used to manufacture treatments for patients with advanced metastatic cancer.  There is a need for the separation kits in support of upcoming therapy treatments.   

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:
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.nih.gov by the due date 11/03/2024 and 12:00 pm noon EST time marked in this notice.  No phone calls will be accepted.