Integration platform of PATs and digital twin for Lyophilization

The Food and Drug Administration's Office of Acquisition and Grant Services is seeking an integrated digital platform for lyophilization research through this combined synopsis and solicitation. The procurement involves a comprehensive digital system that integrates process data, process analytical tools (PATs), and digital twin technology for a laboratory freeze-dryer in a non-GMP environment. The platform must perform closed-loop nonlinear model predictive control, automatically execute integrated control sequences, maintain 99% uptime, and support real-time data acquisition from various sensors and analytical tools while estimating process parameters with high accuracy. The FDA's primary objectives include enhancing advanced lyophilization research capabilities, training workforce on emerging manufacturing technologies, supporting product quality research, enabling real-time process optimization, and advancing quality-by-design principles for lyophilized drug products. This firm fixed-price contract will be evaluated using the lowest price technically acceptable (LPTA) method, with proposal submissions due by September 23, 2025.

This solicitation does not utilize any set-aside designations and no incumbent contractors are identified in the documentation. While specific award values or budget ranges are not disclosed in the available information, the contract includes comprehensive deliverables such as installation, on-site training for six scientists, and a one-year warranty period. The digital platform must achieve bidirectional information flow capabilities and integrate various process analytical technologies with digital twin functionality. Performance will take place at the FDA White Oak Campus in Silver Spring, Maryland, where the integrated system will be installed and implemented. The contract structure emphasizes the critical need for reliable system performance with the 99% uptime requirement and real-time processing capabilities essential for advanced pharmaceutical research applications.