Ambr 250 High Throughput Bioreactor

The Defense Health Agency through the U.S. Army Medical Research Acquisition Activity (USAMRAA) is seeking to procure an Ambr 250 high throughput bioreactor system to enhance monoclonal antibody production capabilities at the Walter Reed Army Institute of Research (WRAIR) Pilot Bioproduction Facility. The procurement specifically targets a brand name or equivalent Sartorius Stedim NA bioreactor system that includes a 12-station workstation, system computer, software, installation services, External Sampling Monitor, chiller, auto cleaning-in-place module, head space gassing, and qualification services. The system must meet comprehensive Minimum Essential Characteristics including the ability to process up to 12 simultaneous cultures for both mammalian and microbial cells, support Design of Experiments (DOE), provide full pH and dissolved oxygen control, and comply with 21 CFR Part 11 requirements. Additionally, the contract requires a 12-month warranty, first-year service and support package with dedicated support team, comprehensive reaction time commitment, preventive maintenance, and training for two operators. Questions are due by June 30, 2025, with quotation responses required by July 15, 2025.

This procurement is designated as a 100% small business set-aside under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) with a size standard of 1,000 employees. The justification documents indicate this is being sole-sourced to Sartorius Stedim North America Inc. as the Original Equipment Manufacturer, as the Ambr 250 is identified as the only fully automated, high-throughput parallel bioreactor system meeting the specific technical requirements. The bioreactor system supports working volumes of 100-250 mL with scalability up to 30 L and enables precise control of temperature (32-37°C), gas flow (up to 550 mL/min), dissolved oxygen monitoring (0-200%), and pH monitoring (2-8.5). The place of performance is at the Walter Reed Army Institute of Research located at 503 Robert Grant Avenue, Silver Spring, Maryland 20910. While specific contract values are not disclosed in the available documents, the procurement represents a significant investment in new technology to support the facility's transition from research to current Good Manufacturing Practices for Phase I clinical trials.