FDA-RFQ-CDER-2025-128755 – Emulate, Inc. Basic Research Chip (Chip-S1 and Chip-R1) and Compound Distribution Kits -BNE
Closed Solicitation Posted
- Solicitation number
- CDER-2025-128755
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- PSC
- AJ12 General Science And Technology R&D Services; General Science And Technology; Applied Research
- Place of performance
- Silver Spring, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services is soliciting quotes for Emulate, Inc. Basic Research Chips (Chip-S1 and Chip-R1) and Compound Distribution Kits to support research conducted by the Division of Applied Regulatory Science in the Center for Drug Evaluation and Research. This procurement seeks commercial products to enable evaluation of microphysiological systems for assessing bronchopulmonary disposition of anti-infective medications and blood-milk barrier functions, providing physiologically relevant in vitro platforms that integrate epithelial and endothelial cells with dynamic fluid flow to better mimic cellular microenvironments than traditional models. The research aims to assess concordance between drug concentration profiles from MPS experiments and clinical studies, potentially informing regulatory decision-making in drug development by evaluating drug penetration into alveolar epithelial lining fluid and comparing blood-milk barrier model outputs with clinical data from sources including the Infant Risk Human Milk Biorepository. This request for quotation follows FAR Part 12 procedures for commercial items acquisition and uses simplified acquisition procedures under FAR Subpart 13.5. Quotes are due September 8, 2025, with the solicitation posted on September 2, 2025, providing a six-day response window.
This opportunity operates under unrestricted full and open competition with no set-aside designations applied, making it available to all qualified contractors. The solicitation specifically references Emulate, Inc. products by name, suggesting either sole source justification or brand name specifications for the required microphysiological system components. The contract will be performed in Silver Spring, Maryland, and falls under NAICS code 541715 for Research and Development in the Physical, Engineering, and Life Sciences, with PSC code AJ12 for General Science and Technology Applied Research services. The government has indicated it is not obligated to make an award and will not reimburse costs incurred during quote preparation and submission. While specific award values are not disclosed in the available excerpt, the procurement supports ongoing regulatory science research programs that may contribute to broader model validation frameworks and integration of advanced in vitro models into nonclinical and clinical development programs.
Notice text
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 Requirements:
1. Utilization of compatible lung and blood-milk barriers’ MPS chips for Emulate’s Zoe Culture Module to enable continuous fluidic flow control.
2. Compatible MPS chips should include:
a. Ten Chip-S1 Basic Research Kits (BRK-S1-WER-24) with the Chip-S1 Stretchable Chip and accompanying Pod Portable Module.
• Seven Chip-R1 Basic Research Kits (BRK-R1-WER-24) with the Chip-R1 Non-Stretchable Chip and accompanying Pod Portable Module.
b. Each kit must include 8 Steriflip filters and ER-1/ER-2 Chip Activation Reagents.
• Step-by-step instructions for the use of Emulate consumable chips.
• Twelve compound distribution kits for drug absorption study.
• Completion of a functional QC test before chip release, with all consumables sterilized before final packaging.
Place of Performance:
Food and Drug Administration
10903 New Hampshire Ave, WO 64 Rm 2032
Silver Spring MD 20993
Attention: Shekh Rahman (Shekh.Rahman@fda.hhs.gov)
Period of Performance:
12 consecutive months commencing upon date of Award.
Please see the attached Statement of Work and corresponding justification for reference/utilization. Quotes are due by email on or before September 8, 2025, by 4:00 P.M. (Eastern Standard Time) and should be sent to brandon.rafus@fda.hhs.gov.
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