SOLICITATION NOTICE
65 -- Generation of Stable eGFP-Expressing iPSC Line and Differentiation of Spinal Motor Neurons from iPSCs
- Notice Date
- 4/6/2021 1:31:00 PM
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95021Q00137
- Response Due
- 4/21/2021 2:00:00 PM
- Archive Date
- 05/06/2021
- Point of Contact
- Mark McNally, Phone: 301-827-5869
- E-Mail Address
-
mark.mcnally@nih.gov
(mark.mcnally@nih.gov)
- Description
- INTRODUCTION PURSUANT TO FAR Subpart 5.2�Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT 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 for Generation of Stable eGFP-Expressing iPSC Line and Differentiation of Spinal Motor Neurons from iPSCs to BrainXell, Inc., 504 S. Rosa Rd., Suite 128, Madison, WI 53719. The rationale for this sole source is BrainXell has been the source for differentiated neurons used by NCATS Therapeutic Development Branch (TDB) for Disease Phenotype Studies with NGY1 Mutant Neurons. In order to maintain consistency of data already collected over the past two years, BrainXell must continue to be the source of these neurons for TDB. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325414 with a small business size tandard of 1,250 employees. 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) 2021-05 with effective date of March 10, 2021. 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 Background 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. Within NCATS, the TDB biology group works to encourage and speed the development of new treatments for diseases with high-unmet medical needs. This acquisition specifically addresses the new therapeutic for NGLY1 rare disease project, which specifically applies breakthroughs in translational science to advancing new treatments for rare diseases. TDB biology is requesting these items to conduct an exploratory study for NGY1 deficiency. The main goal will be to replicate the results of previous studies done for NCATS and confirm that they exist across lines. If it is confirmed, the program will move ahead with cell-based assay development. TDB needs GFP-tagged motor neurons in order to complement the neuronal outgrowth models already established at NCATS. Purpose and Objectives Generation of Stable eGFP-Expressing iPSC Line and Differentiation of Spinal Motor Neurons from iPSCs for Characterization of Disease Phenotype in NGYL1 Mutant Spinal Motor Neurons for the Therapeutic Development Branch (TDB) at the National Center for Advancing Translational Sciences (NCATS). � Description Description� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � ��Cat. # ����������� Qty Generation of Stable eGFP-Expressing iPSC Line������ ����������������������� BX-6021������� 7 Differentiation to Spinal Motor Neurons from iPSCs���� ����������������������� BX-6100������� 4 Shipping via Liquid Nitrogen Vapor Shipper & Return� ����������������������� SH-0500������� 1 Salient Characteristics: Generation of Stable eGFP-Expressing iPSC Line: Ubiquitously expressed CAG-eGFP reporter Inserted at AAVS1 safe-harbor site Delivery of at least 3 vials of iPSCs at ?1.0x106 cells/vial ����������� Differentiation to Spinal Motor Neurons from iPSCs: 10 vials ?2.5x106 neurons/vial (viable) Includes Seeding and Day 4 Supplements From patient iPSC lines 592, 594, 592-corrected (heterozygous), and 592-corrected (homozygous) Cells will be frozen to yield 2.5 million viable cells/vial and shipped overnight via a liquid nitrogen vapor shipper. Complete data package and cells including spreadsheet of raw data as well as a complete data work-up and full report. iPSC lines will be supplied by the Government for this project. An eGFP reporter under the CAG promotor will be inserted at the AAVS1 safe harbor site and clones with stable expression will be selected. These iPSCs will be expanded before neural induction and differentiation. Vials of spinal motor neurons will then be generated. Cells will be frozen to yield 2.5 million viable cells/vial and shipped overnight via a liquid nitrogen vapor shipper. iPSC Lines: 519, 592, 593, 594, KO X-2, 592-corrected (heterozygous), and 592-corrected (homozygous) Delivery Date Within six (6) months after receipt of order. CLOSING STATEMENT This synopsis is not a request for competitive proposals; however, All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency Responses to this notice must include sufficient information to establish the interested parties� bona-fide capabilities of providing products that meet the requirement. Responses that fail to include relevant technical capability information and all terms and conditions may be assessed as not capable of meeting the requirement. 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 05:00 PM Eastern Time, April 21, 2021, and reference number 75N95021Q00137. Responses must be emailed to Mark McNally, Contracting Officer, at mark.mcnally@nih.gov.� All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/45a2df24b20645deb060a7512f451d94/view)
- Place of Performance
- Address: Madison, WI 53719, USA
- Zip Code: 53719
- Country: USA
- Zip Code: 53719
- Record
- SN05964016-F 20210408/210406230116 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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