SOLICITATION NOTICE
66 -- Global Life Sciences/ 3x VIA Thaw L1000, installation and Operational Qualification package.
- Notice Date
- 7/26/2021 11:35:51 AM
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 21-010495
- Response Due
- 8/10/2021 11:00:00 AM
- Archive Date
- 08/25/2021
- Point of Contact
- Grace Wong-Darko, Phone: 3014961199
- E-Mail Address
-
Grace.Wong-Darko@nih.gov
(Grace.Wong-Darko@nih.gov)
- Description
- INTRODUCTION This is not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. 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 Thaw L1000, installation and Operational Qualification package. 2. Background Information The Center for Cellular Engineering (CCE) within the Department of Transfusion Medicine routinely needs to cryopreserve and thaw cells for clinical application. The VIA Thaw L1000 is a cell thawing device that is compatible with current regulations on GMP production of cell therapies. There are several features that are unique to the VIA Thaw L1000 when compared to other cell bag thawing equipment available on the market: � Thaw Endpoint determination: thaw endpoint to be precisely determined through data collected from 5 infrared sensors. The sensors monitor temperature of the cell bag during the thawing process � Completely dry: no liquids are used in the VIA Thaw L1000 to thaw a bag � Standardized thawing: pre-set thaw profiles, transmitted to all VIA Thaw units and locked to one profile for added reliability. Profiles ensure consistent thawing from run to run and user to user. � Thaw Record: a record of each step in the thawing process that traces the temperature of a cell bag through the thawing process. � Integrated Icon-based Graphical User Interface: Simple to operate with a user-friendly screen display � Integration with Chronicle Software: VIA Thaw can be easily integrated into Chronicle GMP Manufacturing Automation Software. This web-based digital platform enables thawing processes to be developed centrally, standardized between VIA Thaw units and across sites, and provides remote access to thaw records from all linked units. � Does not require any other equipment (such as an external temperature probe or thermometer) to operate. � Designed to reduce contamination: may be cleaned using standard wipes and removable thawing tray controls any spillage. � Flexible heat transfer bed: molds to the shape of the frozen bag and the lid softly shuts to enclose the sample. This allows for a large variety of bags and volumes to be used with the system. � Hardware safety interlock : Heaters are hard-stopped if any plate goes above the 37�C temperature maximum. 3. Purpose or Objective: Purchase of 3x Via Thaw L1000 closed-system cell thawing system that will allow for enhanced recovery and viability of cell products post cryopreservation within CCE. 4. Delivery: �180 DAYS A.R.O. 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 Via Thaw L1000� 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� Via Thaw L1000 Devices ����������� 3x �Installation and Operational qualification package ����������� 3x� Thawing Tray (Pack of 2) TBA 30065 ���� ������ 1x� Chronicle 25 inclusive credits� MYC_10025 ���� ������ 1x� Chronicle Pre-GMP Hosting setup� MYC_30001 ����������� 1x �Chronicle Gateway (SW license)� MYC_40001 ����������� 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 Delivery of ViaThaw L1000 devices Installation of ViaThaw L1000 Freeze devices Performance of Installation Qualification Performance of Operational Qualification Delivery of binder documenting acceptance of installation and operational qualification. 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. Delivery of ViaThaw L1000 devices Installation of ViaThaw L1000 devices Performance of Installation Qualification Performance of Operational Qualification 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 by Steven Highfill. 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 Solution 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 August 10th, 2021, 2:00 PM Eastern time and must reference solicitation number 21-010495. 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.""
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/266bc7d3f9034132a2ff340d8fc8ff4e/view)
- Place of Performance
- Address: Marlborough, MA 01752, USA
- Zip Code: 01752
- Country: USA
- Zip Code: 01752
- Record
- SN06073718-F 20210728/210728203259 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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