Gproms Lyophilization Modeling Toolbox or Equal Tender

• Country: USA
• Summary: Gproms Lyophilization Modeling Toolbox or Equal
• UST Ref No: 140810406
• Deadline: 20 May 2026
• Financier: Self Financed
• Purchaser Ownership: Government
• Tender Value: Refer Document
• Notice Type: Tender
• Document Ref. No.: FDA-75F40126Q00155
• Purchaser's Detail:
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• 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 P...
• Documents:

 Tender Notice

Documents.zip