Attachment 1_Purchase Description.pdf
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- Solicitation number
- 75N95023Q00462
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This document contains a purchase description for the custom synthesis of 9 antisense oligonucleotides for a neurotoxicity study. The National Institutes of Health requires 9 customized ASOs synthesized and delivered by July 2023 according to specified sequences. Each ASO is required at a final concentration of 13 mg after HPLC purification in 1.5 mL Strle tubes. The period of performance is two weeks from July 1-15, 2023. The related federal contract opportunity is a pre-solicitation from the Department of Health and Human Services for custom synthesis of the 9 ASOs to support a neurtoxicity study.
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Purchase Description Statement of Need and Purpose:
Background Information and Objective:
Generic Name of Product:
Purchase Description:
Salient Characteristics:
Quantity:
Delivery Date:
Period of Performance:
Option(s):
9.0.0.2.20101008.1.734229
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| Include a general narrative of the need of the requirement and the desired results.: This requisition establishes a contract to manufacture 9 antisense oligonucleotides (ASOs) commercially. These ASOs are the necessary starting material to be used to evaluate if a platform based on neuronal cell cultures can be used for the rapid and reliable prediction of neurotoxicity associated with administering ASOs. The antisense oligonucleotides will be used for research and require high sequence specificity and purity. |
| Include a brief history of the requirement, the importance of the requirement, and the overall program objectives.: There are over 7,000 different rare diseases that affect 350 million globally and about 35 million people in the U.S. Sadly, about half of these rare diseases have onset in childhood, and the vast majority (~95%) have no FDA-approved treatment. Most rare diseases have a known single gene cause, making them potentially amenable to oligonucleotide therapeutics like ASOs. ASOs are short strands of modified RNA and DNA that bind to target RNA and can act by modulating splicing, inhibiting translation, or inducing mRNA degradation. ASOs are increasingly being deployed as individualized medicines as they are rapidly customizable, relatively easy to deliver, and inexpensive to manufacture. Although there is a growing number of clinical examples and safety data for ASOs, there is a need to reduce the cost and development timelines to test these therapies in more patients with rapidly progressing life-threatening diseases faster without compromising safety. |
ASOs have seen clinical success, with at least eight approved ASO drugs and many more in clinical trials. However, the broader development of high-affinity gapmer ASOs for rare diseases has been hampered by hepatotoxicity. Recent developments in multicellular 3D neuronal spheroids offer a promising platform for high-throughput neurotoxicity screening.
IDT DNA will synthesize and deliver 9 antisense oligonucleotides as a test case for treating rare diseases. This approach potentially represents a new means to treat rare diseases, as it can also be adapted to target other human genes.
| Specify the generic name of the component or system, e.g., freezer, microscope, cell sorter, etc.: Quote Number: QTE-283449. Generation of 9 ASOs for neurotox study |
| Specify 1) trade name; 2) product’s brand name; 3) manufacturer's name; 4) model, type, catalog, and/or part number(s.): Custom Synthesis of 9 Antisense Oligonucleotides (ASOs) for Neurotox study |
| Specify the significant, essential physical, functional, performance, or material element(s) (the distinguishing characteristic) of a product, system, component, or service required. Specify the functions that a system or component must perform to meet the Government’s objectives. Include required levels of performance, features or characteristics of the system or component that are essential to meet the government’s objectives. Specify the Government’s minimum acceptable standards.: IDT DNA will synthesize and deliver 9 antisense oligonucleotides. The antisense oligonucleotides will be customized according to sequences specified by NCATS. The antisense oligonucleotides will be synthesized, purified using standard desalting methods, and normalized to the required quantity and concentration. The material will ship dry, at ambient temperature in smaller tubes. (Oligonucleotides to be delivered in 1.5 Strle Tubes) |
Quantity: each ASO 13 mg final concentration after HPLC
| Specify quantity. : 9 ASOs |
| Specify desired delivery date after receipt of order (30-60 days.): July 2023 |
| Specify period of performance for software license, warranty, or maintenance agreements.: The period of performance is two weeks. |
• Start date: July/1/2023
• End date: July/15/2023 Specify if options for additional quantities or options to extend the term of the contract for service agreements.: NA
File details come from the government source that posted it. Updated .