INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal)

Summary (Newest Update)

Background The United States Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER) and the Office of Pharmaceutical Quality Research (OPQR), is seeking to acquire an advanced lyophilization process modeling and simulation platform. This initiative aims to enhance the study of emerging pharmaceutical manufacturing technologies. The FDA intends to award a sole source contract to Siemens Government Technologies, Inc., indicating that only one responsible source can meet the agency's requirements. Work Details The contractor shall provide a Lyophilization Modeling Toolbox with the following salient characteristics: - Nonlinear Predictive Control (NL) for Lyophilization, optimized for high-performance computing to perform large-scale predictive modeling of lyophilization cycles. - Operational Intelligence & Data Integration, including a base system capable of aggregating real-time operational data for 'Digital Twin' validation. - High-Fidelity Dynamic Simulation, simulating transient process events using first-principles mathematical equations. - Advanced Material & Thermodynamic Property Architecture for modeling complex pharmaceutical formulations. - Automated Global System Analysis (GSA) tools for parameter estimation and sensitivity analysis. - Customizable Modeling Environment & API for creating custom models and integrating with external data systems. - Scalable Enterprise Access with flexible licensing types. - Regulatory-Grade Maintenance and Support through a multi-year subscription model, including continuous software enhancement and technical support. Additionally, the contractor must provide maintenance support via email/web conference, licenses including necessary upgrades, one day of project support, and access to online training materials. Period of Performance The contract will be performed over a 12-month period. Place of Performance The contract will be performed at the location specified by the FDA.