FDA Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services

The U.S. Department of Health and Human Services (HHS) is seeking a vendor to provide a mechanistic chromatography modeling software license, including support and maintenance services, for a period of 12 months. The software should have a mechanistic modeling environment, streamlined modeling workflow, and seamless lab integration. The vendor must provide delivery of software updates, one business-day response to software defect inquiries, and availability of feature upgrades. The contract will be a firm-fixed-price purchase order, and the government intends to award the contract to the responsible quoter whose quote is considered lowest price technically acceptable. Key features and requirements of the software include: • Mechanistic modeling environment for conventional pharmaceutical processes • Streamlined modeling workflow from calibration experiments to simulation • Seamless lab integration through optimal linking to AKTA system and UNICORN software • Visual tools for easy interpretation of simulation outputs • Component-centric data structure enables plug and play with different methods, system parts, and columns • Collaboration and knowledge management shared database within and between projects • Tamper-proof and back-traceable data and user management • Simulates preparative liquid chromatography processes with a computer • Creates digital twins of downstream processes using mechanistic models • Enables increased process understanding for smarter and faster process development • Applies to a wide range of molecules and applications from early process development to late stage, scale-up, troubleshooting, and chemistry, manufacturing, and controls (CMC) • Custom modeling capabilities to create user-defined models • Parameter estimation from experimental data to support model validation • Global sensitivity analysis to analyze the impact of inputs and model parameters on process outputs • Ability to estimate physical properties of components using only a few experiments • Ability to run optimization and characterization • Mechanistic model libraries including different adsorption isotherms that can be applied to different modes of chromatography • Mechanistic model libraries for membrane separation