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HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH has floated a tender for Independent Verification and Validation of Engineered Cell Lines. The project location is USA and the tender is closing on 16 May 2025. The tender notice number is 75N992-25-RFI-107, while the TOT Ref Number is 118549552. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country : USA
Summary : Independent Verification and Validation of Engineered Cell Lines
Deadline : 16 May 2025
Other Information
Notice Type : Tender
TOT Ref.No.: 118549552
Document Ref. No. : 75N992-25-RFI-107
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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Description
BACKGROUNDThe Advanced Research Projects Agency for Health (ARPA-H) Resilient Systems Office seeks to support the procurement of independent verification and validation (IV&V) of the engineered cell lines utilized in the Resilient Extended Automatic Cell Therapies (REACT) program.
The REACT program is developing wireless implantable medical devices for the surveillance and treatment of chronic diseases. These devices will interface with patients through a software platform, allowing for confirmation of therapy delivery or current disease status. The “Living Pharmacy” device will deliver tunable therapeutic molecules on demand, while the “Living Sentinel” device will track disease biomarker status. Both devices have similar components including engineered cells (to deliver therapies or track biomarkers) and electronic control with patient interface through a simple software platform.
Cellular engineering for human-implantable devices requires standardization and reproducibility. To this end, a key component of the REACT effort is developing a manufacturing process for the routine engineering of cells to form standardized cell lines that can either deliver therapies or detect biomarkers. Independent verification and validation (IV&V) is essential for developing Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) during preclinical assessment and scale up for manufacturing. This includes benchmarking therapeutic production, limits of detection, differentiation processes, and establishing purity.
PURPOSE OF THE REQUEST FOR INFORMATION
Seeking Capabilities Statements: The Government is considering a FAR based acquisition to meet the needs described in Section 3 below. The Government seeks feedback from industry on this approach, including information regarding alternate solutions that may be capable of meeting the Government-s full range of requirements.
Engagement and Insights Gathering: We encourage industry...
Active Contract Opportunity
Notice ID : 75N992-25-RFI-107
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)
General Information
Contract Opportunity Type: Sources Sought (Original)
Original Published Date: May 01, 2025 11:25 am EDT
Original Response Date: May 16, 2025 04:00 pm EDT
Inactive Policy: 15 days after response date
Original Inactive Date: May 31, 2025
Initiative: None
Classification
Original Set Aside:
Product Service Code: B537 - SPECIAL STUDIES/ANALYSIS- MEDICAL/HEALTH
NAICS Code: 541990 - All Other Professional, Scientific, and Technical Services
Place of Performance: Washington, DC USA
Documents
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