- Country: USA
- Summary: Independent Verification and Validation of Engineered Cell Lines
- UST Ref No: 118549552
- Deadline: 16 May 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 75N992-25-RFI-107
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- Description:
- 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... - Documents:
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CLICK HERE TO LOGINIndependent Verification and Validation of Engineered Cell Lines - USA Tender
The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH, a Government sector organization in USA, has announced a new tender for Independent Verification and Validation of Engineered Cell Lines. This tender is published on USARFP under UST Ref No: 118549552 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 2025-05-16.
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.
