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- Human and Mouse Hepatopac plates for the National Center for Advancing Translational Sciences
- Solicitation number
- 75N95024Q00494_SB
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This document is a Purchase Description for Human and Mouse Hepatopac plates for the National Center for Advancing Translational Sciences (NCATS). The Malaria project aims to develop a drug that can treat the malaria infection with a single oral dose, requiring extremely metabolically stable compounds. To evaluate these low clearance drug candidates, NCATS requires the Hepatopac system, which allows for long-term hepatocyte incubation to assess metabolic clearance.
The Purchase Description specifies the required products, including 2 each of Human Hepatopac plates, Mouse Hepatopac plates, stromal control plates, acellular control plates, maintenance medium, and assay medium. The delivery timeframe is 30-60 days after placing the order. This Purchase Description is related to a Small Business Sources Sought notice for the same requirement, which aims to identify qualified small business sources capable of providing the required products. Interested companies are requested to submit capability statements addressing their qualifications by August 13, 2024.
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Version 11-30-2016-1 FAR Part 11—Describing Agency Needs
PURCHASE DESCRIPTION
1. Statement of Need and Purpose: The Malaria project aims to develop a drug that can last 7-10 days in a patient to be able to resolve the malaria infection with a single dose of the drug.
Because of that, the Medicinal Chemists have developed methods to make very metabolically stable drugs, which, in turn, display very low clearances in in vitro systems. To evaluate such low clearance drugs, it is necessary to use systems that are meant for long incubations. The Hepatopac system is patented by Massachusetts Institute of Technology and exclusively licensed to BioIVT, LLC. This system allows for 5-7 days of incubation, which allows the evaluation of the metabolic clearance of such low clearance drugs.
2. Background Information and Objective: The Malaria project aims to develop a drug that is capable of treating the malaria infection in a person with a single oral dose. For that, the compounds have to be extremely resistant to metabolism. The project has been very successful in avoiding metabolism but that rendered the usual methods employed by the DMPK group to measure metabolic stability incapable of measuring such low metabolic stability. To better support this project, we aim to test these compounds in the Micropatterned Hepatocyte Co-cultures (HEPATOPAC) system which allows for a long-term hepatocyte incubation which is capable of assessing the low clearance of these drug candidates.
3. Generic Name of Product: Human and Mouse Hepatopac plates.
4. Purchase Description:
1 – 2x Human Hepatopac plates 2 – 2x Mouse Hepatopac Plates 3 – 2x Stromal control plates 4 – 2x Acellular control plates 5 – 2x Maintenance medium 6 – 2x Assay medium
5. Salient characteristics Human or mouse hepatopac plates will be seeded and cultured by
BioIVT and shipped in maintenance media to NCATS. The hepatocytes are micropatterned and co-culture with stromal cells to allow for the hepatocytes to retain activity for a longer period.
Additional stromal only and acellular control plates are included, which are help with non-specific binding determination as well as evaporation control over the long incubation time. The necessary media for maintenance and application are also provided.
6. Quantity: As specified in Purchase Description above.
7. Delivery Date: 30-60 days after placing the order.
Version 11-30-2016-1 FAR Part 11—Describing Agency Needs
8. Period of Performance: N/A
9. Option(s): N/A
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