FDA-RFQ-CDER-2025-128755 - Emulate, Inc. Basic Research Chip (Chip-S1 and Chip-R1)... Tender

Procurement Summary

Country: USA

Summary: FDA-RFQ-CDER-2025-128755 - Emulate, Inc. Basic Research Chip (Chip-S1 and Chip-R1) and Compound Distribution Kits -BNE

Deadline: 08 Sep 2025

Other Information

Notice Type: Tender

TOT Ref.No.: 125599801

Document Ref. No.: CDER-2025-128755

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

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Tender Details

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.

Minimum Kit Requi...
Active Contract Opportunity
Notice ID : CDER-2025-128755
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION
Office: FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
Original Published Date: Sep 02, 2025 07:58 am EDT
Original Date Offers Due: Sep 08, 2025 04:00 pm EDT
Inactive Policy: 15 days after date offers due
Original Inactive Date: Sep 23, 2025
Initiative: None

Classification
Original Set Aside: No Set aside used
Product Service Code: AJ12 - GENERAL SCIENCE AND TECHNOLOGY R&D SERVICES; GENERAL SCIENCE AND TECHNOLOGY; APPLIED RESEARCH
NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance: Silver Spring, MD USA

Documents

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