Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services

Mechanistic chromatography modeling software • Mechanistic modeling environment for conventional pharmaceutical processes including a graphical interface with drag and drop functionality. • Mechanistic model libraries including different adsorption isotherms that can be applied to different mode of chromatography such as Affinity, Ion-exchanger, HIC, mixed-mode... • Mechanistic model libraries for membrane separation • 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 to support the fulfilment of quality by design obligation. • Component-centric data structure enables plug and play with different methods, system parts, and columns. • Collaboration and knowledge management shared databased 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. Review the attached SOW for full description of the requirement.