G-Rex500M Bioreactors

The National Institutes of Health (NIH), Clinical Center, Center for Cellular Engineering (CCE) intends to award a sole source purchase order to Wilson Wolf Manufacturing for the acquisition of five cases of G-Rex500M-CS (2-pack box) bioreactors and associated freight. The bioreactors are used in validated FDA-regulated manufacturing processes for cell-based therapies supporting NIH clinical trials. Interested sources may submit a capability statement with supporting documentation demonstrating their ability to satisfy the requirement without additional validation or interruption to patient care. • The requirement is for five cases of G-Rex500M-CS bioreactors. • The bioreactors must meet the Government's technical and quality requirements. • Substituting another manufacturer's product would require extensive qualification and validation testing. • Capability statements should include legal business name, address, Unique Entity ID, CAGE code, and point-of-contact information.