Notice of Intent Global Life Sciences Solutions USA LLC

Title: Notice of Intent to Sole Source Global Life Sciences Solutions USA LLC Sepax C-Pro Cell Processing System

NAICS Code: 339112- Surgical and Medical Instrument Manufacturing (Small Business Standards 1,000 Average Number of Employees)
Product Service Code: 6640
Place of Performance: Bethesda, MD 20892

POTS: 23-007574-1

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) intends to award a fixed price contract to Global Life Sciences Solutions USA LLC located in Marlborough, MA 01752 on a sole source basis to provide quantity four (4) ViaFreeze, quantity three (3) ViaThaw and quantity three (3) Sepax C-Pro devices to complement government existing equipment used in the other Clinical Centers for Cellular Engineering facilities, for consistency and reproducibility of results and provide simplified program management.

The purpose of this requirement is to acquire the Sepax C-Pro Cell Processing System.  It is a multipurpose solution allowing diverse and dedicated applications that includes but is not limited to enrichment, magnetic bead incubation, spinoculation, concentration, washing, dilution, and splitting.  The VIA Freeze range of controlled-rate freezers are liquid nitrogen-free.  They combine customizable freezing profiles, electronic control systems, and a conduction cooling method to optimize GMP-compliant cryopreservation.  In addition, they are versatile devices increasing productivity without changing processes.  VIA Thaw™ dry thawers provide automated, controlled, and consistent thawing of cellular products in cryobags.  The Sepax C-Pro Cell Processing System consisting of ViaFreeze, ViaThaw and Sepax C-Pro devices will be utilized for the processing, storage and thawing of items such as final products, and product intermediates at the CCE/Clinical Center cGMP Clinical Cell Processing Facility.

The only known sole source capable of suppling the equipment is Global Life Sciences Solutions USA LLC. 

Line Item/Product No/Description/Quantity
0001-VFQ_30010-VIA Freeze Quad Controlled Rate Freezer-Quantity 4
0002-ASY_30101-Thermocouples T-Type with Calibration for use with VIA Freeze Range (Pack Of 4)-Quantity 4
0003-ASY_30144-SBS Adapter Adjustable Rack For Duo Or Quad (Requires Lid Spacer)-Quantity 8
0004-VFQ_30025-Lid Spacer VIA Freeze Quad 80mm-Quantity 4
0005-ASY_30070-SBS Adapter 2 x 250ml Bag Plate For Quad (Includes Foam Insert)-Quantity 4
0006-ASY_30063-SBS Plate 10 x 5ml COOK Vial (Requires Lid Spacer)-Quantity 16
0007-ASY_30020-SBS Plate 48 x 2ml Standard Size Vial-Quantity 16
0008-MYC_30001-Chronicle Pre-GMP Hosting setup-Quantity 4
0009-MYC_10025-Chronicle 25 inclusive credits-Quantity 4
0010-29389327-E-Binder IQOQ VIA Freeze-Quantity 4
0011-28992659-Commissioning and Qualification Performance-Quantity 4
0012-Blank-Blank-Quantity 1
0013-29403109-VIA Thaw L1000-Quantity 3
0014-29458851-Thawing Tray Assembly-Quantity 3
0015-29389329-E-Binder IQOQ VIA Thaw-Quantity 3
0016-28992659-Commissioning and Qualification Performance-Quantity 3
0017-29264741-Sepax C-Pro-Quantity 3
0018-29264734-Neatcell Sepax C-Pro protocol software-Quantity 3
0019-29264736-CultureWash Sepax C-Pro protocol software-Quantity 3
0020-2938932-E-Binder IQOQ Sepax-Quantity 3
0021-28992659-Commissioning and Qualification Performance-Quantity 3

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 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 and time marked in this notice.