Fda Notice of Intent to Award a Sole Source and Related Rfq: Human Induced Pluripotent... Tender

Procurement Summary

Country : USA

Summary : Fda Notice of Intent to Award a Sole Source and Related Rfq: Human Induced Pluripotent Stem Cell-Derived Macrophages (Hipsc-Macs)

Deadline : 25 Mar 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 99092558

Document Ref. No. : 75F40124Q122639

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

NOTICE OF INTENT TO AWARD A SOLE SOURCE (and associated RFQ/Sol for the sole source procurement): The U.S. Food and Drug Administration (FDA)/National Center for Toxicological Research (NCTR) intends to award a sole source, firm fixed price purchase order to Fujifilm Cellular Dynamics, Inc., 465 Science Dr, Madison, WI 53711-1000, under the authority of FAR 13.106-1(b)(1).

The FDA/NCTR, Division of Systems Biology (DSB) has an approved scientific study (S00913) requiring the use of Human induced pluripotent stem cell-derived macrophages (hiPSC-MACs). The macrophages must be from the lot number previously used for this study (lot# 106775).

Background

Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) are an important tool used in drug development for the evaluation of cardiotoxicity. These cells, however, lack the ability to mimic in vivo cellular changes in response to inflammation or infection, which is important in the study of infection-/inflammation-induced myocyte injury. Recently, a co-culture model of hiPSC-CMs and hiPSC-MACs was employed to mimic Covid-19-induced myocyte injury. To further characterize the model for immune-cardiotoxicity assessment, the Division of Systems Biology at NCTR aims to setup and refine the model at NCTR. The work and information gathered under this study will be critical in determining the feasibility of using the model in the future in the context of regulatory use, such as predictive toxicology studies for assessing the potential immune-cardiotoxicity of candidate drugs. product ingredients, impurities, homogenates/extracts of foods, etc., particularly human-specific biological products for which animals are not good model systems. In order to move forward with this study and maintain consistency in the study, the Division of Systems Biology requires the purchase of macrophages from the same lot (Lot # 106775) as were used for the initial study.

This notice is being published ...
Active Contract Opportunity Notice ID 75F40124Q122639 Related Notice Department/Ind. Agency HEALTH AND HUMAN SERVICES, DEPARTMENT OF Sub-tier FOOD AND DRUG ADMINISTRATION Office FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Special Notice (Original)
All Dates/Times are: (UTC-05:00) CENTRAL STANDARD TIME, CHICAGO, USA
Original Published Date: Mar 19, 2024 05:06 pm CDT
Original Response Date: Mar 25, 2024 10:00 am CDT
Inactive Policy: 15 days after response date
Original Inactive Date: Apr 09, 2024
Initiative: None

Classification
Original Set Aside:
Product Service Code: 6505 - DRUGS AND BIOLOGICALS
NAICS Code: 541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance:

Documents

 Tender Notice

75F40124Q122639-Sole-Source-Notice-of-Intent.pdf

75F40124Q122639.pdf