gPROMS lyophilization Modeling Toolbox (or equal)

Description

The objective is to establish a new contract for Siemens modeling and simulation platform license, featuring advanced process modeling. FDA's OPQR has a requirement to obtain an advanced lyophilization process modeling and simulation platform to study emerging pharmaceutical manufacturing technologies. For Quoter�s software to be deemed acceptable, the following salient characteristics shall be met: Lyophilization Modeling Toolbox � Nonlinear Predictive Control (NL) for Lyophilization: Utilizes a highly parallelized, equation-oriented architecture optimized for high-performance computing (HPC) to perform large-scale, high-fidelity predictive modeling of time-dependent lyophilization cycles. � Operational Intelligence & Data Integration: Must include a base system (such as XHQ) capable of aggregating and visualizing real-time operational data from multiple manufacturing sources to support "Digital Twin" validation. � High-Fidelity Dynamic Simulation: Capable of simulating transient process events and complex equipment dynamics�including freezing, primary drying, and secondary drying�using first-principles mathematical equations rather than empirical data. � Advanced Material & Thermodynamic Property Architecture: Supports the modeling of complex pharmaceutical formulations through comprehensive databases for excipients and APIs to track critical properties like moisture content and chemical purity throughout the stabilization process. � Automated Global System Analysis (GSA): Built-in mathematical tools to perform parameter estimation from experimental data and Global Sensitivity Analysis (GSA) to identify influential process parameters and validate Quality by Design (QbD) design spaces. � Customizable Modeling Environment & API: Features an open, equation-oriented language for creating custom first-principles models from scratch, complemented by a robust Application Programming Interface (API) for integration with external data systems like Python, Excel, or Electronic Lab Notebooks. � Scalable Enterprise Access: Supports flexible licensing types including "Named User" for specific researchers and "Small System" base configurations to manage data exchange across physical or virtual assets. � Regulatory-Grade Maintenance and Support: Provided through a multi-year subscription model that includes continuous software enhancement, technical support, and alignment with established Licensed Software Designation Agreements (LSDA). Maintenance and Technical Support At minimum the contractor must: � Provide support via email and/or web conference. � Licenses shall include maintenance, support, and any upgrades necessary to maintain the system. � Provide one day of project support. Training The Contractor shall provide: � Access to online training material in Altair resources Please review the attached RFQ_FDA-75F40126Q00155 document for all details.