NOI to Sole Source 17 Nucleocounter® NC-202 devices with IOPQ kits

17 Nucleocounter® NC-202 devices with IOPQ kits

• Product Service Code: 6640
• NAICS Code: 334516
• Place of Performance:

Bethesda, MD 20892 USA

POTS: 25-005553

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 firm fixed-price purchase order on a sole-source basis to Chemometec Inc. of 3920 Veterans Memorial Highway, Suite 3, Bohemia, New York 11716-1074. This award will be for the procurement of 17 Nucleocounter® NC-202™ Devices with IOPQ kits for the Center for Cellular Engineering.

The purpose of this acquisition is to procure seventeen (17) Nucleocounter® NC-202™ Devices with IQ/OQ/PQ kits. These devices will be used to quantify cell numbers in cell therapy products intended for patients. The FDA requires accurate quantification of cell numbers to determine the correct dosage for cell therapies. Inaccurate cell quantification can expose patients to potential risks, including:

• Inadequate dosages that may not effectively treat the patient.
• Overdosages, which may lead to side effects like cytokine storm.

The Nucleocounter® NC-202™ is a widely used device in cell therapy and comes with a suitable IQ/OQ/PQ package to meet FDA expectations. The device is capable of counting cell concentrations up to 1x10^7 cells per ml, even in samples with significant red blood cell contamination.

The device supports the following applications:

• Count & Viability – For most mammalian cell types (e.g., cancer cells, HEK cells).
• PBMC – For immune cells (e.g., PBMCs, T-cells, B-cells).
• Large Single Cells – For hepatocytes, MSCs.
• Aggregated Cells – For stem cells, tissue-derived cell lines.
• Microcarriers – For cell culture on microcarriers.
• Blood – For whole blood or samples with high RBC counts.
• CEF – For chicken embryo fibroblasts.
• Insect Cells – For common insect cells like SF9.
• Yeast – For common yeast cells like S. cerevisiae (with yeast license).

The Nucleocounter® NC-202™ is widely used in cGMP (current Good Manufacturing Practice) operations and can be integrated with electronic batch records, allowing for the automatic transfer of data. The device complies with 21 CFR Part 11/GMP guidelines and can be seamlessly incorporated into existing manufacturing workflows, ensuring data integrity and regulatory compliance.

As the industry standard in the cell therapy field, the NC-202 device comes with an IQ/OQ/PQ package, which qualifies the device in accordance with FDA standards. Utilizing alternative devices would necessitate an extensive requalification of Center for Cellular Engineering (CCE) processes, incurring additional costs and delays. These delays could impact the timely delivery of therapies to patients and influence the outcomes of clinical trials.

Product Details Required for this Action:

Instruments:

• 970-2020: Nucleocounter® NC-202™ (17)
• 982-3007: Installation by CM Product Specialist (17)
• 951-0003: Secure Mode License for NC-202 (17)
• 982-3013: Nucleocounter® NC-202™ 21 CFR Part 11 Qualification (17)

Consumables, Accessories, & Test Kits:

• 912-2021: Nucleocounter® NC-202™ IQ/OQ Kit (17)
• 912-2022: NC-202 PQ Kit (17)
• 941-0024: Via2-Cassette™ (100 pcs per box) (51 boxes)

Service:

• 980-5220: GMP-ready Service Plan NC-202 (annual) 
  • Includes:
    • On-site IQ/OQ and PQ
    • On-site NC-202/PC qualification of 21 CFR Part 11 licensed software by Chemometec specialists
    • Consumables and materials
    • Enhanced warranty (free repairs)
    • Access to application protocols, specialists, priority phone and email support
    • Qualification Report
    • Freight

Chemometec Inc., a small business, is the sole manufacturer of the Nucleocounter® NC-202™.  There are no other known sources that can supply this equipment.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation 13.501 Special documentation requirements for sole source acquisitions exceeding the Simplified Acquisition Threshold. 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 submit capability statements 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 Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Shasheshe Goolsby, Lead Contract Specialist, shasheshe.goolsby@nih.gov by May 15, 6:00AM EST.

Please send your capability statement only. This is not a request for quotation.