SAM #FDA-75F40126Q00155

FDA Solicitation for Siemens Lyophilization Modeling Toolbox Software License, Maintenance, and Training

The FDA Center for Drug Evaluation and Research is seeking to procure an advanced lyophilization modeling and simulation software toolbox for pharmaceutical process modeling. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Drug Evaluation and Research / Office of Pharmaceutical Quality / Office of Quality Research - OEMs and Vendors: - Siemens (referenced as the Original Equipment Manufacturer for the modeling platform) - Altair (referenced for online training resources) - Products/Services Requested: - Lyophilization Modeling Toolbox software license for 1 user - Features required: nonlinear predictive control, operational intelligence, high-fidelity dynamic simulation, advanced material and thermodynamic property architecture, automated global system analysis, customizable modeling environment and API, scalable enterprise access, regulatory-grade maintenance and support - Maintenance and technical support (email/web conference, upgrades, one day of project support) - Access to online training materials (Altair resources) - Unique/Notable Requirements: - Software must be Siemens gPROMS Lyophilization Modeling Toolbox or equivalent - Delivery required within 30 days of award - Subscription model for maintenance and support - Regulatory-grade compliance and customizable API environment - Option for subscription renewal after initial 12-month period - Place of Performance and Delivery: - FDA Center for Drug Evaluation and Research, Silver Spring, MD - FDA Office of Acquisition and Grant Services, Rockville, MD

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.

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