MaxCyte ExPERT GTx Electroporation Device and Installation/Operational Qualification (IQ/OQ)
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institutes of Health (NIH), Clinical Center, on behalf of its Center for Cellular Engineering (CCE), intends to award a firm-fixed-price contract on a sole source basis to MaxCyte, Inc. for the purchase of a MaxCyte ExPERT GTx Electroporation Device and associated Installation Qualification/Operational Qualification (IQ/OQ) services. This acquisition is for informational purposes only and does not constitute a request for quotations. The place of performance is Bethesda, MD. The NAICS code is 541714 (Research and Development in Biotechnology). No set-aside applies.
Scope of Requirement
The CCE manufactures cell-based therapies under Current Good Manufacturing Practices (cGMP). The current MaxCyte Gen2 GT electroporation system will be unsupported by mid-2026, necessitating a transition to the ExPERT GTx system to maintain continuity of clinical manufacturing protocols and cGMP compliance. The ExPERT GTx device will replace the current system and includes installation, IQ/OQ, and preventative maintenance services.
Key technical capabilities of the MaxCyte ExPERT GTx platform include:
- FDA Master File supported platform, simplifying regulatory submissions.
- GMP-compliant closed electroporation system suitable for clinical manufacturing.
- High transfection efficiency in primary cells (T cells, NK cells, hematopoietic stem cells).
- High cell viability and preservation of cellular function.
- Clinical-scale processing capability, supporting billions of cells per run.
- Scalable platform for research, clinical, and commercial manufacturing.
- Non-viral delivery capability, reducing complexity and cost.
- Compatibility with multiple cargo types (DNA, mRNA, CRISPR RNPs, proteins).
- Highly reproducible and standardized manufacturing processes.
- Established clinical track record in cell and gene therapy manufacturing.
Contract & Justification
This is a firm-fixed-price, sole source acquisition. The NIH intends to award to MaxCyte, Inc. because they are 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 known vendor provides an electroporation platform that supports clinical-scale electroporation for cell therapy manufacturing, operates within a fully closed cGMP-compliant system, maintains compatibility with existing NIH CCE validated protocols, and provides manufacturer-certified IQ/OQ services. The acquisition is being conducted under FAR 13.106-1(b)(1), which permits soliciting from a single source when only one is reasonably available.
Response & Submission
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.
Responses, referencing POTS: 26-003578, must be submitted electronically to Shasheshe Goolsby at shasheshe.goolsby@nih.gov by March 13, 2026, at 4:00 PM ET.