Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services

Background
The Food and Drug Administration (FDA) is seeking to purchase a new license for mechanistic chromatography modeling and simulation software. This sophisticated modeling approach is crucial for understanding and predicting the behavior of chromatographic systems, which is essential in the biopharmaceutical industry. The software will aid in digital transformation by integrating mechanistic models into downstream process development and manufacturing processes of biologics, allowing for better prediction of chromatographic behavior and compliance with regulatory standards.

The goal is to enhance method development, optimize processes without extensive trial-and-error, and maintain comprehensive records for traceability and reproducibility.

Work Details
The contract requires the following features in the mechanistic chromatography modeling software:
- A graphical interface with drag-and-drop functionality for ease of use.
- Mechanistic model libraries that include various adsorption isotherms applicable to different modes of chromatography such as Affinity, Ion-exchanger, HIC, and mixed-mode.
- Libraries for membrane separation.
- A streamlined modeling workflow from calibration experiments to simulation.
- Seamless integration with AKTA systems and UNICORN software.
- Visual tools for interpreting simulation outputs to support quality by design obligations.
- A component-centric data structure that allows plug-and-play capabilities with different methods, system parts, and columns.
- Collaboration features with a shared database for knowledge management across projects.
- Tamper-proof data management with back-traceable user actions.
- Simulation capabilities for preparative liquid chromatography processes.
- Creation of digital twins of downstream processes using mechanistic models.
- Custom modeling capabilities for user-defined models.
- Parameter estimation from experimental data to support model validation and global sensitivity analysis to assess the impact of inputs on process outputs.