75N95025Q00091

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Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
iPSC-derived microglia cells (40 vials of microglia cells (> 4 million cells/vial).
Contracting Office
National Center for Advancing Translational Sciences (NCATS)

Contact Points

Primary Contract Specialist

GIULIANA
FALLER
giuliana.faller@nih.gov
NAICS Code Number
541714
Research and Development in Biotechnology (except Nanobiotechnology)
Small Business Size Standard
1,000 employees
FPDS Classification Code
6505
Estimated Period of Performance
N/A
Delivery of Goods
7 days after receipt of order.
Set-Aside Status
Not Set Aside
Competition Status
Non-Competitive
Vendor Name
BrainXell, Inc.
Vendor Address
455 Science Dr Ste 130
Madison, WI 53711-1067
United States
Single-Sole Source Determination
This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, BrainXell's is the only vendor in the marketplace that can provide the products required by the NCATS.

BrainXell's iPSC-derived microglia cells have been thoroughly validated, demonstrating the expression of characteristic microglial surface markers such as CD45, CD11b, CX3CR1, P2RY12, and TMEM119. Immunocytochemistry shortly after cell plating indicates robust expression levels of TREM2 and IBA1. These microglia cells reveal phagocytic capabilities and can be activated to secrete various cytokines, including IL-6 and TNF-á. Their suitability for high-throughput assay development is notably enhanced by a simple one-step cell seeding process, optimizing their utility in experimental setups.

The Tox21 initiative has successfully employed BrainXell's iPSC-derived microglia cells to develop a high-throughput screening platform aimed at evaluating environmental chemicals for potential neuroinflammatory effects. This platform supports ongoing collaborative studies with the Environmental Protection Agency focused on identifying neurotoxic chemicals. Switching to a different vendor at this juncture would necessitate extensive efforts to re-validate the quality of the new microglia cells, and to ascertain whether they meet the required standards for detection.

Furthermore, transitioning to an alternative supplier would incur significant time and effort to re-optimize the assay conditions, including parameters such as cell seeding densities, culture media conditions, pre-incubation durations, and compound treatment times. This disruption would substantially hinder our current study timeline and progress. Therefore, it is imperative for us to continue utilizing BrainXell's iPSC-derived microglia cells to maintain the momentum and integrity of our assays and research endeavors.
The use of these cells provides continuity and stability for our assays, which are critical for the successful advancement of our research goals. Changing vendors at this point poses a substantial risk, potentially derailing ongoing projects and collaborations due to required re-qualifications.
Background/Description of Requirement

PURPOSE AND OBJECTIVES:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.
The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions
In order to screen tens of thousands of known drugs and compounds in vitro, NCATS (then NCGC), NTP, EPA, and FDA initiated the Tox21 collaboration with the goal of reducing the cost and time involved in traditional toxicology testing methodologies. NCATS has conducted numerous screenings against the Tox21 compound collection since its inception nearly a decade ago. We conducted these screenings using cell-based assays, primarily focusing on various targets and toxicity pathways. Currently, Tox21 is working on a project to explore how environmental chemicals affect neuroinflammation, specifically targeting microglia cells. To achieve this objective, Tox21 requires iPSC-derived microglia cells as a model to evaluate their 10K compound library.

DESCRIPTION OF REQUIREMENT
The Tox21 group (NCATS) is developing a project to identify the chemical activation of microglia. We require these iPSC-derived microglia cells for screening purposes. We will use these microglia cells to screen the compounds from the Tox21 collaborators.
• 40 vials of microglia cells (> 4 million cells/vial).
• Microglia, derived from human iPSC line
• Marker Expression: Confirmed expression of microglia surface markers including: CD45, CD11b, CX3CR1, P2RY12, and TMEM119. Immunocytochemistry shortly after plating microglia reveals prominent expression of TREM2 and IBA1.
• Function: Human Microglia (BX-0900) demonstrate phagocytosis and can be stimulated to secrete a variety of cytokines, including IL6 and TNFá.
• High-throughput: Human microglia can be used to seed in a 1536-well plate in one step and are suitable for high-throughput assay development.
PURPOSE

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.