Description
The National Institutes of Health (NIH) intends to award a firm-fixed-price contract to MaxCyte, Inc. for the purchase of a MaxCyte ExPERT GTx Electroporation Device and associated Installation Qualification/Operational Qualification (IQ/OQ) services. The device will be used for cell-based therapies and must meet cGMP manufacturing standards. The contract includes installation, operational qualification, and preventative maintenance services. The key features of the MaxCyte ExPERT GTx platform include FDA Master File support, GMP-compliant closed electroporation system, high transfection efficiency, and clinical-scale processing capability.
* Clinical-scale electroporation technology
* cGMP-compliant cell therapy manufacturing systems
* FDA-compatible regulatory documentation support
* Manufacturer-validated IQ/OQ services
* High transfection efficiency in primary cells
* Clinical-scale processing capability
* Scalable platform supporting research, clinical, and commercial manufacturing stages
Attached files
The solicitation documents live at the source — open the bid source above to download them.