SOLICITATION NOTICE
Q -- Human Cortical Glutamatergic Neurons
- Notice Date
- 8/31/2018
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIHDA201800526
- Archive Date
- 9/21/2018
- Point of Contact
- Mark E. McNally, Phone: (301) 827-5869, Jeffrey Schmidt, Phone: (301) 402-1488
- E-Mail Address
-
mcnallyme@mail.nih.gov, schmidtjr@mail.nih.gov
(mcnallyme@mail.nih.gov, schmidtjr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) intends to award a purchase order to BrainXell, Inc. for services to grow human cortical glutamatergic neurons. The rationale for this sole source is BrainXell utilizes a unique, proprietary mixture of growth factors that accelerate the rate of maturation of the neurons into fully mature neurons in less than five (5) days after thawing. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325414 - Biological Product (except Diagnostic) Manufacturing and the small business size standard 1,250. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2005-100, dated August 22, 2018. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source. DESCRIPTION OF REQUIREMENT Project Description Title : Human Cortical Glutamatergic Neurons Background : The National Center for Advancing Translational Sciences (NCATS) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers. The Therapeutics for Rare and Neglected Diseases (TRND) biology program's mission is to encourage and speed the development of new treatments for diseases with high-unmet medical needs. N-glycanase 1 (NGLY1) deficiency is an ultra rare, multi-system disease characterized by neurological disorders. To study the pathophysiology of this disease and to facilitate therapeutic development, we have generated induced pluripotent stem cells (iPSCs) from NGLY1 patient fibroblasts as a disease model. The iPSCs now need to be differentiated into disease relevant cells types, specifically, cortical glutamatergic neurons. In patient iPSC-derived neurons, we will investigate cellular phenotypes caused by loss of NGLY1 function and aberrant deglycosylation. In a parallel study, once a disease-specific phenotype is identified, we will perform high-throughput screening of NCATS' compound collection to identify lead compounds for drug development. The contractor will grow the stem cells into actual neurons that have the NGLY1 phenotype. BrainXell will send the neurons to TRND for further testing. The contractor shall be responsible for validating the patient-derived induced pluripotent stem cells (iPSCs), producing the neurons, and assessing the quality of the neurons. Project Requirements : The contractor will receive frozen iPSCs, provided by TRND, that were derived from patients with a lysosomal storage disease. The iPSCs TRND is sending out have the disease phenotype. Contractor will thaw and culture the iPSC line to validate its quality. If necessary, contractor will select and expand high-quality sub-colonies within the culture before neural differentiation. Contractor will produce 20 vials of human cortical glutamatergic neurons from the iPSCs lines. Contractor will freeze all cells and ship them along with seeding supplements that only BrainXell manufactures which will make possible for the neurons to grow and survive in a 1536-well plate environment. Shipment will be overnight using a liquid nitrogen vapor shipper to TRND. Other important considerations : • Experience in large quantity production of human cortical glutamatergic neurons from iPSCs lines and capability of high repeatability of these iPSC derived neurons. • Capability to accelerate the rate of maturation of the neurons into fully mature neurons in less than five (5) days after thawing. • Understanding of the project and technical approach. Purpose and Objectives To procure human cortical glutamatergic neurons differentiated from patient-derived iPSCs for the TRND laboratory. Period of Performance The period of performance shall be four (4) months. Contract Type The Government intends to issue a firm fixed price purchase order for this requirement. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice must include sufficient information to establish the interested parties' bona fide capabilities of providing the product or service. The price quote shall include: total price, delivery date after receipt of order, and any other information or factors that may be considered in the award decision. Such factors may include: technical approach, ability to meet or exceed the delivery date/period of performance, and cost/price. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by 3:00 PM Eastern Time, Thursday, September 6, 2018, and reference number NIHDA201800526. Responses must be submitted electronically to Contract Specialist Mark McNally at mcnallyme@mail.nih.gov. Fax responses will not be accepted. Contracting Office Address : 6001 Executive Blvd Room 3287, MSC 9534 Bethesda, MD 20892-9534 All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/NIHDA201800526/listing.html)
- Record
- SN05067798-W 20180902/180831231449-87ba55689618d34e6cd3077d3f399c88 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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