Thermo Fisher Scientific (Life Technologies) Reagents and Consumable Materials for Cell Therapy Manufacturing
The NIH Clinical Center's Center for Cellular Engineering intends to award a firm-fixed-price sole-source contract to Thermo Fisher Scientific for reagents and consumable materials used in manufacturing cell-based therapies for clinical trial patients. The required materials, including AIM V media, Dynabeads, and other specified reagents, have been validated for cGMP manufacturing and approved by the CCE Quality Assurance Department. Substituting these materials would require extensive requalification and validation, causing cost increases, delays, and potential disruptions to patient treatment. Interested responsible sources may submit a capability statement demonstrating they can provide the exact materials and quantities with supporting documentation without requiring revalidation. The work will be performed at the NIH Clinical Center.