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: 26-008363

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 following items are required for this procurement:

Units/Part Number/Description

1/E-GTX-A/Expert GTx Flow Electroporation Platform for cGMP and Clinical Applications, Generation 3 with accessories

1/IQOQ/IQOQ Services and Installation

1/Estimated Freight

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: 26-008363 must be submitted electronically to:

Shasheshe Goolsby

Team Leader

Hospital and Laboratory Support Division

Office of Acquisitions and Logistics Management

National Institutes of Health

Email: shasheshe.goolsby@nih.gov