Global Life Sciences/ 3x VIA Freeze Quad Controlled Rate Freezers, installation and Operational Qualification package.

INTRODUCTION
THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Center for Cellular Engineering (CCE), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to:

Global Life Sciences Solutions USA, LLC.

100 Results Way

Marlborough, MA, 01752-3078

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334516 with a Size Standard 1000.


REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-03, February 16, 2021. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold.


STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION

1. Title: Global Life Sciences/ 3x VIA Freeze Quad Controlled Rate Freezers, installation and Operational Qualification package.

2. Background Information:  The Center for Cellular Engineering is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes in support of more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of cellular therapies for INDs and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product by the NIH. To provide these services, CCE operates a core facility for the manufacture, storage, and distribution of cellular therapy products. CCE manufactures cellular therapy products from more than 800 collections from patients and healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using current good manufacturing practices (cGMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs, approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. 

3. Purpose or Objective: Purchase of 3x Via Freeze controlled rate freezers and associated equipment with an Installation and Operational Qualification package.

4. Delivery:  7/1/2021.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

The Center for Cellular Engineering manufactures cell based therapies for patients who either 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 FDA in 21 CFR 210, 211, 600 and 1271. The Center for Cellular Engineering wishes to purchase 3 new, Via Freeze devices from Cytiva. In addition, this project includes the purchase of an Installation Qualification and Operational Qualification package that is used to demonstrate to outside agencies, such as the FDA, that the device is operating as specified and will perform as required in manufacturing processes and hence minimizes the risk to patients as the likelihood a manufacturing process failing is minimized due to incorrect operation of the device.

1. Objectives

• The manufacturer will supply ViaFreeze  devices.
• The manufacturer’s representative will perform installation qualification device.
• The manufacturer’s representative will perform operational qualification of the device.

1.1 Period of Performance

The period of performance is a one off delivery followed by an onsite visit for qualification of the device and should occur within 3 months of procurement.

1.2 Equipment/Supplies/Services

            3x  ViaFreeze Devices

            3x Installation and Operational qualification package

            3x  Thermocouples

            6x  SBS Adapter Adjustable rack for Duo or Quad

            3x  Lid Spacer

            3x SBS Adapter Bags

            12x SBS Vial Spacers

            12x SBS Plate Adapters

            3x Commissioning and Qualification

            3x IOQ binders

2.            References

These operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271.

3.            Requirements

The deliverables are the device, and a completed IOQ binder documenting that the device meets the expectations listed on the installation and operational qualification tests. 

3.1          Tasks

1. Delivery of ViaFreeze devices
2. Installation of ViaFreeze devices
3. Performance of Installation Qualification
4. Performance of Operational Qualification
5. Delivery of binder documenting acceptance of installation and operational qualification.
6. Sign off on documentation by Center for Cellular Engineering Quality Assurance.

3.2         The contractor shall conduct the following tasks:

List the tasks (no. and name) in sequential order by phase (if applicable).  Provide sufficient level of detail to enable the prospective contractor to plan personnel utilization and other requirements with maximum efficiency.

1. Delivery of ViaFreeze devices
2. Installation of ViaFreeze devices
3. Performance of Installation Qualification
4. Performance of Operational Qualification
5. Delivery of binder documenting acceptance of installation and operational qualification.

Installation and operational qualification will occur in building 10 the Center for Cellular Engineering.

4.            Schedules/Milestones

• The contractor shall maintain a single project schedule from which various project reports shall be produced.  The following reports shall be provided:
• Installation Qualification Report
• Operational Qualification Report

5.          Who Does What When Report

Inspections and Acceptance Requirements Anna Namata/Jeannette Pola Bota from the Quality facilities and materials group at CCE will

• Receive devices and ensure that they were shipped under the appropriate conditions
• That the packaging integrity is not compromised
• That all ordered materials have arrived
• That serial numbers match the documentation
• Any discrepancies are reported to Cytiva/

CCE Quality Assurance

• Ensure that the Installation and Operational qualification are completed appropriately
• All documentation in the binder for the Installation and Operational qualification is complete and free from errors.
• That the devices are fit for use.

5.1        Logistical Requirements

• All materials will be delivered to the

RM#3C720, Building 10

10 Center Drive

Bethesda

Maryland 20892

• Deliveries are 7am to 6pm and must be signed for
• All packaging must be intact and and a packing slip with lot#s and and certificates of analysis or conformance must be supplied along with any calibration certificates and operational software.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

This system is on site and has been validated for use on CC patients.  It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by Global Life Sciences Solutions USA, LLC.  With the continuation of using the same system will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, and the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
 

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
All responses must be received by May 27th, 2020, 4:00 PM Eastern time and must reference solicitation number 21-007499. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."