Definitive Contract 75F40126C00098

<p>The Food and Drug Administration awarded a definitive contract to Physical Sciences Inc. for advanced control techniques for product temperature during pharmaceutical lyophilization on September 1, 2026, with a ceiling value of $1,019,732 under BAA FY26C1BP25.</p> <p>Place of performance is Andover, MA. The contract runs through August 31, 2027, on a firm fixed price basis with no set-aside applied.</p>

<p>The Food and Drug Administration awarded a purchase order to Siemens Industry Software Inc. for an integration platform of process analytical technology systems and digital twin technology for lyophilization, valued at $199,779.12, with an award date of September 30, 2025. Performance will be completed by September 29, 2026 and will take place in Silver Spring, Maryland. The order carries firm fixed-price pricing and no set-aside designation.</p>

The Food and Drug Administration awarded a $1,085,530 definitive contract to Genentech Inc. on September 11, 2025, for advanced research and development in regulatory science addressing hybrid randomized controlled trials in longitudinal settings, with emphasis on causal methodologies for managing diverse missing data patterns. The contract was issued under a Fiscal Year 2025 Broad Agency Announcement for Advanced Research and Development of Regulatory Science, which solicited proposals across...

The Food and Drug Administration awarded a purchase order to Sentrysciences, Inc. valued at $55,000 on June 15, 2026 for an artificial intelligence and computational statistics platform to detect and classify protein aggregates in biosimilar drug products. Work is performed in Silver Spring, Maryland. The platform combines machine learning to generate morphological fingerprints of protein aggregates, differentiate particles by stress type and product, and employ neural network-based metric...

Research Center Pharmaceutical Engineering GMBH (RCPE) has been awarded a definitive cost no fee contract from the U.S. Department of Health and Human Services Food and Drug Administration (FDA). With a potential value of $1,256,778, this contract is to provide precision modeling tools for evaluating continuous manufacturing control approaches through a high-fidelity digital twin for industry and FDA use. RCPE will deliver its services in Austria, with Technische Universitaet Graz (TU Graz)...

The U.S. Food and Drug Administration (FDA) has awarded a $246,067.50 firm-fixed-price purchase order contract to Aantilia LLC, a minority-owned, economically disadvantaged women-owned small business based in Austin, Texas. The contract is for the delivery of an Automated Dry Heat Diffusion System with 24 vertical cells to support the Division of Product Quality Research's (DPQR) research on transdermal and topical drug product quality and safety. The system will be used to conduct approximately...

The Food and Drug Administration awarded a $2.05M definitive contract to The Trustees of Princeton University on September 29, 2022, to develop an integrated platform for continuous RNA nanoparticle formulation and drying. This cost-reimbursable contract, with an ultimate completion date of March 31, 2025, was awarded without set-aside designation through a Broad Agency Announcement seeking research and development proposals to advance regulatory science. The work is being performed in...

<p>The National Cancer Institute awarded a definitive contract to Physical Sciences Inc. for development of a mini-lyophilizer for pharmaceutical product formulation on September 20, 2013, under a total small business set-aside, with a ceiling value of $995,267.88.</p> <p>This cost-plus-fixed-fee research and development contract supports basic biomedical research. Place of performance is Andover, MA. The ultimate completion date is March 19, 2017.</p>

<p>The U.S. Food and Drug Administration (FDA) awarded a $124,852.00 firm fixed-price purchase order to Sequoia Research Products LTD, a foreign-owned for-profit organization, for a &quot;DRUGS FOR RE-POSITIONING STUDY&quot; with an ultimate completion date of October 17, 2015. The contract was not set aside for any specific business type. The place of performance is in Great Britain, United Kingdom.</p>

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Product Quality and Research (OPQR) has awarded a firm-fixed-price Purchase Order to Proteinsimple, a division of Bio-Techne Corporation, to provide replacement parts and components for the agency's ProteinSimple CE-SDS/cIEF (Maurice) protein characterization and analysis system. The $38,269.69 contract has a completion date of September 30, 2024 and does not utilize a set-aside designation....