INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal)

The FDA’s Center for Drug Evaluation and Research, through its Office of Pharmaceutical Quality Research, intends to acquire a specialized lyophilization process modeling and simulation platform to advance research into emerging pharmaceutical manufacturing technologies. This acquisition is being pursued as a sole source procurement under FAR 6.302-1 because Siemens Government Technologies, Inc. is identified as the only source capable of providing the necessary system, specifically the gPROMS Lyophilization Modeling Toolbox or an equivalent, which offers a highly parallelized, equation-oriented architecture optimized for high-performance computing to model transient lyophilization events including freezing, primary drying, and secondary drying. The platform must support nonlinear predictive control, integrate operational intelligence through a base system like XHQ for digital twin validation, and include an API for connectivity with Python, Excel, and electronic lab notebooks. The solution will be delivered as a 12-month subscription for one named user, encompassing software, licensing keys, and digital user manuals via CD, DVD, or download, with no requirement to return physical media. Technical support will be provided via email or web conferencing, along with one day of project support and access to online training resources through Altair. The contract is structured as a firm fixed price purchase order with a performance period of 12 months at the place of performance in Silver Spring, Maryland. This action is not a competitive solicitation but an intent to sole source, and while no bid is required for award, interested parties may submit capability statements by June 2, 2026, to Terina Hicks at terina.hicks@fda.hhs.gov; no telephone inquiries are permitted, and the government reserves the right to decide whether to proceed with sole source award based on received submissions.