The Department of Health and Human Services, through the NIH Clinical Center's Center for Cellular Engineering, intends to award a sole source purchase order to Wilson Wolf Manufacturing for five cases of G-Rex500M-CS bioreactors. These bioreactors are used in validated FDA-regulated manufacturing processes for cell-based therapies supporting NIH clinical trials, and substituting another product would require extensive requalification, increase costs, and potentially delay patient treatments. The government believes Wilson Wolf is the only known source capable of providing the validated bioreactors without additional validation or interruption to care. Any responsible source that can demonstrate an equivalent product meeting all technical and quality requirements without further validation may submit a capability statement. The government will evaluate all submissions but retains sole discretion to proceed with the sole source award.