Thermo Fisher Scientific (Life Technologies) Reagents and Consumable Materials for Cell Therapy Manufacturing

The National Institutes of Health (NIH) Clinical Center, Center for Cellular Engineering (CCE), intends to award a firm-fixed-price contract on a sole-source basis to Thermo Fisher Scientific (Life Technologies) for reagents and consumable materials used in the manufacture of cell-based therapies for patients enrolled in clinical trials at the NIH Clinical Center. The required materials include AIM V MED CTS, DYNABEADS CD3/CD28 CTS, CTS AIM-V MEDIUM MINUS, ACK LYSING BUFFER, RPMI 1640, and CTS AIM-V MEDIUM MINUS. The CCE has validated these materials for their manufacturing processes and approved them for use in an FDA-regulated manufacturing process. • The contract will be for a firm-fixed-price. • The required materials must be provided in specific quantities. • The materials must be used in the manufacture of cell-based therapies for patients enrolled in clinical trials at the NIH Clinical Center. • The CCE has validated the required materials for their manufacturing processes and approved them for use in an FDA-regulated manufacturing process. • Substitution of these materials would require extensive requalification and validation of manufacturing processes, resulting in additional cost, significant time delays, and potential delays to patient treatment.