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.