Purchase of Human Cells and Cell Culture Reagents

The Food and Drug Administration's Office of Acquisition and Grant Services has issued a Special Notice regarding the purchase of human cells and cell culture reagents for mission-critical research activities. This procurement involves four different human cell types and specific reagents necessary to thaw cryopreserved cells and maintain them in in-vitro cell culture environments. The FDA's Division of Applied Regulatory Science requires these materials to support evaluation of drug safety, metabolism, and efficacy as part of their regulatory research and decision-making processes. The agency has published a Notice of Intent to Sole Source this contract to Lonza Walkersville, Inc. under FAR Part 6.302-1, citing that only one responsible source can satisfy the agency's requirements. The contract is anticipated to be a Firm Fixed Price arrangement with a one-year period of performance.

The primary objective of this procurement is to acquire specific quantities of human cells including mammary epithelial cells, small airway epithelial cells, lung microvascular endothelial cells, hepatocytes, and peripheral blood mononuclear cells, along with corresponding growth medium kits. Interested contractors have until August 22, 2025, at 3:00 PM EST to submit capability statements demonstrating their ability to meet the contract requirements and potentially challenge the sole source determination. The FDA plans to award the contract to Lonza Walkersville within ten days of the notice unless another organization proves capable of fulfilling the requirements. Deliveries are scheduled for May 26th and August 25th, 2025, to the FDA White Oak Campus in Silver Spring, Maryland, with specific packaging, marking, and authorization requirements. Alternative vendors must demonstrate they can provide the exact cell types and reagents needed to support the FDA's drug evaluation research across different organ systems.