gPROMS lyophilization Modeling Toolbox (or equal)

The contract seeks the acquisition of a modeling and simulation platform from Siemens or an equally capable vendor to support advanced lyophilization process modeling for pharmaceutical manufacturing research under the FDA’s Office of Pharmaceutical Quality Research. The platform must feature a specialized Lyophilization Modeling Toolbox built on a high-performance, equation-oriented architecture capable of simulating the full transient dynamics of freeze-drying cycles—including freezing, primary drying, and secondary drying—using first-principles mathematical models rather than empirical data. It must integrate real-time operational data from manufacturing systems to enable Digital Twin validation, support comprehensive databases for tracking pharmaceutical material properties such as moisture content and chemical purity, and include automated tools for parameter estimation and Global Sensitivity Analysis to validate Quality by Design design spaces. The system must offer an open, customizable modeling environment with a robust API for integration with external tools like Python and Excel, along with scalable licensing options for both named users and small system deployments. Continuous maintenance and technical support must be provided through a multi-year subscription including software upgrades and alignment with Licensed Software Designation Agreements, with support delivered via email or web conference and one day of dedicated project support included. Online training resources from Altair must also be provided to end users. The contract is structured as a Firm Fixed Price acquisition under the Lowest Price Technically Acceptable (LPTA) evaluation methodology, with award expected after review of technically compliant responses submitted by the May 20, 2026 deadline. Performance must commence by July 10, 2026, with full delivery required no later than 30 days after contract award, and the 12-month contract period runs through July 9, 2027. The platform must be delivered in digital form via CD, DVD, or download, and all deliverables, including software and documentation, must meet Section 508 accessibility requirements, with contractors obligated to provide Accessibility Conformance Reports or checklists and remedy any non-compliance at their own expense. The contracting office requires full adherence to federal supply chain security clauses prohibiting the use of covered telecommunications equipment, ByteDance applications, and unmanned aircraft systems from certain foreign entities, with strict compliance required for subcontractors, privacy training, and small business subcontracting reporting. Invoicing must be submitted electronically through the Treasury’s Invoice Processing Platform, and acceptance of deliverables will occur at the recipient site in Silver Spring, Maryland, with government inspection and formal acceptance to be completed within 30 business days of delivery.