MAXCYTE EXPERT GTX ELECTROPORATION DEVICE AND INSTALLATION/OPERATIONAL QUALIFICATION (IQ/OQ)

MaxCyte ExPERT GTx Electroporation Device and Installation/Operational Qualification (IQ/OQ)

Product Service Code (PSC): 6640 – Laboratory Equipment and Supplies
NAICS Code: 541714 – Research and Development in Biotechnology (except Nanobiotechnology)
Size Standard: 1,000 Employees

Place of Performance:
National Institutes of Health
Clinical Center
Bethesda, MD 20892

POTS: 26-003578

Description

This notice is issued for informational purposes only and does not constitute a request for quotations. A solicitation will not be issued and quotations will not be requested.

The National Institutes of Health (NIH), Clinical Center, Office of Purchasing and Contracts, on behalf of the Center for Cellular Engineering, intends to award a firm-fixed-price contract on a sole source basis to MaxCyte, Inc., Rockville, MD 20850, for the purchase of a MaxCyte ExPERT GTx Electroporation Device and associated Installation Qualification/Operational Qualification (IQ/OQ) services.

Background

The Center for Cellular Engineering (CCE) manufactures cell-based therapies for patients who have either exhausted all standard treatment options or have no available standard therapies.

CCE manufacturing operations are regulated under Current Good Manufacturing Practices (cGMP) as mandated by the U.S. Food and Drug Administration (FDA) under:

• 21 CFR Part 210

• 21 CFR Part 211

• 21 CFR Part 600

• 21 CFR Part 1271

The electroporation device is used to introduce genetic material (DNA, RNA) and proteins into cells during the development and manufacturing of cell-based therapies.

The current electroporation system in use at CCE is the MaxCyte Gen2 GT model, which will no longer be supported by the manufacturer beginning in mid-2026. To maintain continuity of ongoing clinical manufacturing protocols and ensure continued compliance with cGMP manufacturing standards, the Center must transition to the MaxCyte ExPERT GTx system.

The ExPERT GTx device will replace the current system and includes installation, operational qualification (IQ/OQ), and preventative maintenance services required to maintain validated manufacturing equipment in a regulated cGMP environment.

Technical Capabilities of the MaxCyte ExPERT GTx

The MaxCyte ExPERT GTx platform provides several capabilities required for clinical cell therapy manufacturing, including:

• FDA Master File supported platform, simplifying IND and CMC regulatory submissions

• GMP-compliant closed electroporation system suitable for clinical manufacturing

• High transfection efficiency in primary cells, including T cells, NK cells, and hematopoietic stem cells

• High cell viability and preservation of cellular function following electroporation

• Clinical-scale processing capability, supporting billions of cells in a single run

• Scalable platform supporting research, clinical, and commercial manufacturing stages

• Non-viral delivery capability, reducing complexity and cost associated with viral vectors

• Compatibility with multiple cargo types, including DNA, mRNA, CRISPR RNPs, proteins, and other molecules

• Highly reproducible and standardized manufacturing processes

• Established clinical track record in cell and gene therapy manufacturing

The MaxCyte ExPERT GTx is widely recognized as a clinical manufacturing standard for electroporation-based gene modification in cell therapy production.

Sole Source Justification

MaxCyte, Inc. is the original equipment manufacturer and sole provider of the proprietary ExPERT GTx electroporation platform, associated disposable processing assemblies, and required IQ/OQ validation services.

No other vendor is known to provide an electroporation platform that:

• Supports clinical-scale electroporation for cell therapy manufacturing

• Operates within a fully closed, cGMP-compliant system

• Maintains compatibility with existing validated protocols used within the NIH CCE manufacturing environment

• Provides manufacturer-certified IQ/OQ qualification services required for regulated GMP manufacturing

As a result, MaxCyte, Inc. is the only source reasonably available to provide the required equipment and associated qualification services.

Authority

This acquisition is being conducted in accordance with:

FAR 13.106-1(b)(1) – Soliciting from a Single Source

Under this authority, contracting officers may solicit from a single source when the contracting officer determines that only one source is reasonably available.

Acquisitions conducted under FAR Part 13 – Simplified Acquisition Procedures are exempt from the competition requirements of FAR Part 6.

Responses

This notice is not a request for quotations. However, interested parties may submit capability statements demonstrating their ability to provide equipment and services equivalent to the MaxCyte ExPERT GTx electroporation platform.

Capability statements must clearly demonstrate the ability to provide:

• Clinical-scale electroporation technology

• cGMP-compliant cell therapy manufacturing systems

• FDA-compatible regulatory documentation support

• Manufacturer-validated IQ/OQ services

The Government will evaluate capability statements received in response to this notice. The determination not to compete this requirement is solely within the discretion of the Government.

Submission Instructions

Responses referencing POTS: 26-003578 must be submitted electronically to:

Shasheshe Goolsby
Team Lead Contract Specialist
Office of Purchasing and Contracts
NIH Clinical Center

Email: shasheshe.goolsby@nih.gov