- Country: USA
- Summary: FDA-RFQ-CDER-2025-128755 - Emulate, Inc. Basic Research Chip (Chip-S1 and Chip-R1) and Compound Distribution Kits -BNE
- UST Ref No: 125599801
- Deadline: 08 Sep 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: CDER-2025-128755
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- Description:
- Description
This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the procedures of FAR Part 12-Acquisition of Commercial Items. This requirement is being solicited under unrestricted full and open competition, using the Simplified Acquisition Procedures of FAR Subpart 13.5 and is issued as a request for quotation (RFQ). The government is not obligated to make an award. The Government is not obligated to pay costs incurred by the Contractor during quote preparation and quote submission.
Background: The Division of Applied Regulatory Science (DARS) in the Center for Drug Evaluation and Research (CDER) is conducting a research program to evaluate the utility of a microphysiological system (MPS) in assessing the bronchopulmonary disposition of anti-infective milk barriers, provide a physiologically relevant in vitro platform that integrates key components components—epithelial and endothelial cells, along with dynamic fluid flow—to better mimic the cellular microenvironment compared to traditional in vitro models. This research aims to assess the concordance between drug concentration profiles obtained from MPS experiments and clinical studies, offering alternative or complementary approaches to clinical research. Evaluating the lung alveolar model may provide critical insights regarding drug penetration into alveolar epithelial lining fluid (ELF) and support regulatory decision-making in drug development. Similarly, assessing the blood-milk barrier model will determine its predictive accuracy by comparing outputs with available clinical data, including the Infant Risk Human Milk Biorepository (HMB), as well as nonclinical data from various studies. The findings from this study may contribute to the broader regulatory science framework by informing model validation, study design, and the integration of advanced in vitro models into nonclinical and clinical development programs.
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CLICK HERE TO LOGINFDA-RFQ-CDER-2025-128755 - Emulate, Inc. Basic Research Chip (Chip-S1 and Chip-R1) and Compound Distribution Kits -BNE - USA Tender
The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION, a Government sector organization in USA, has announced a new tender for FDA-RFQ-CDER-2025-128755 - Emulate, Inc. Basic Research Chip (Chip-S1 and Chip-R1) and Compound Distribution Kits -BNE. This tender is published on USARFP under UST Ref No: 125599801 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-09-08.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
