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.
