gPROMS lyophilization Modeling Toolbox (or equal)

Project ID: FDA-75F40126Q00155 FederalOpportunitiesSynopsis Solicitation

Overview

Agency	Food and Drug Administration
Deadline	05/20/26
Posted	05/06/26
Estimated Value	Not Provided
Set Aside	None
NAICS	513210 - Software Publishers
PSC	DH10 - IT And Telecom - Platform As A Service: Database, Mainframe, Middleware
Location	Silver Spring, MD 20993 United States

Description

Primary Latest Change

Summary

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.

Summary (Newest Update)

Background The Department of Health and Human Services (HHS) is seeking to enhance public health by leveraging advanced mechanistic modeling and digital twin technologies for pharmaceutical process development. This contract aims to support ongoing initiatives in stabilizing complex biologics, vaccines, and advanced therapeutic medicinal products (ATMPs). The focus is on acquiring a lyophilization process modeling and simulation platform that is essential for ensuring the long-term stability and shelf-life of heat-sensitive pharmaceuticals. Work Details The contractor will provide an advanced lyophilization modeling toolbox with the following salient characteristics: - Nonlinear Predictive Control (NL) for Lyophilization, optimized for high-performance computing to perform predictive modeling of lyophilization cycles. - Operational Intelligence & Data Integration, including a base system capable of aggregating real-time operational data to support 'Digital Twin' validation. - High-Fidelity Dynamic Simulation for simulating transient process events using first-principles mathematical equations. - Advanced Material & Thermodynamic Property Architecture to model complex pharmaceutical formulations and track critical properties. - Automated Global System Analysis (GSA) tools for parameter estimation and sensitivity analysis. - Customizable Modeling Environment & API for creating custom models and integrating with external data systems. - Scalable Enterprise Access with flexible licensing options. - Regulatory-Grade Maintenance and Support through a multi-year subscription model that includes software enhancement and technical support. Additionally, the contractor must provide maintenance support via email/web conference, include necessary upgrades, and offer one day of project support. Training will consist of access to online training materials. Place of Performance The geographic location(s) for performance are not explicitly stated in the solicitation.

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