SOLICITATION NOTICE
Q -- Human Cortical Glutamatergic Neurons
- Notice Date
- 2/16/2018
- 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
- NIHDA201800049
- Archive Date
- 3/8/2018
- Point of Contact
- Mark E. McNally, Phone: (301) 827-5869, Jeffrey Schmidt, Phone: (301) 402-1488
- E-Mail Address
-
mark.mcnally@nih.gov, schmidtjr@mail.nih.gov
(mark.mcnally@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. 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) 2005-97, dated January 24, 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. The group has previously developed multiple assays for quantitative high throughput screening to find novel compounds, which may be used to treat lysosomal storage diseases such as Niemann-Pick disease types A, C1 and C2. The hypothesis for this project is that neurons exhibiting Niemann-Pick disease phenotypes will have increased lysosomal accumulation and substrate accumulation in lysosomes. The contractor will grow stem cells into actual neurons that have the Niemann-Pick phenotype. The contractor 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 will have the disease phenotype. The contractor will thaw and culture the iPSC line to validate its quality. If necessary, the contractor will select and expand high-quality sub-colonies within the culture before neural differentiation. The contractor will produce 20 vials of human cortical glutamatergic neurons from the iPSCs lines. The cortical glutamatergic neurons will be frozen at 5 million neurons/vial in 100 μL of freezing medium with a total batch size of 20 vials. The contractor will freeze all cells and ship them along with seeding supplements which will make it 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 Within three (3) months from time of award. 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 date, 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 12:00 p.m. Eastern Standard Time, Wednesday, February 21, 2018, and reference number NIHDA201800049. Responses may 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 3150, MSC 9559 Bethesda, MD 20892-9559 "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/NIHDA201800049/listing.html)
- Record
- SN04826864-W 20180218/180216231213-d8a029c520de72edd3e76b3c0fcfe7ae (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |