Inactive

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: 75N95023Q00628 TITLE: Generation of clonal iPSC lines that can be differentiated into macrophages to measure lysosomal exocytosis. CLASSIFICATION C... NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: 75N95023Q00628 TITLE: Generation of clonal iPSC lines that can be differentiated into macrophages to measure lysosomal exocytosis. CLASSIFICATION CODE: 6505 – Drugs and Biologicals NAICS CODE: 541714 – Research and Development in Biotechnology (except Nanobiotechnology) RESPONSE DATE: August 28, 2023, 1 pm EST PRIMARY POINT OF CONTACT: Giuliana C. Faller Giuliana.faller@nih.gov Phone: 301-480-9789 DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). 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 translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people’s lives. Included in this process is the development of new and promising therapeutics for the potential modulation of immune system. NCATS is interested in the obtaining engineered cell models that can be used to investigate macrophage function and utilized for high-throughput screening of small molecules. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541714 – Research and Development in Biotechnology (except Nanobiotechnology) with a Size Standard of 1,000 Employees. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-04 dated June 2, 2023. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The purpose of this project is to generate clonal iPSC lines that can be differentiated into macrophages to measure lysosomal exocytosis. We aim to extend this assay for high throughput screening to identify molecules that could modulate lysosome exocytosis. Contractor will provide (1) iPSC (802-30F) cell line (knockin-small, cell clone) with HiBiT tag in the CD63 locus. (2) THP1 cells (knockin-small, cell Pool) with HiBiT tag in the CD63 locus. The PAM site of the sequence after homologous recombination will be mutated to prevent further cutting of the DNA. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The NCATS Early Translation Branch (ETB) collaborates with investigators at NIH and in the academic, biopharmaceutical and nonprofit sectors to generate probes for studying a diverse cross-section of human biology, focusing specifically on new targets and untreatable diseases. The project team is collaboratively developing high-throughput screening assays to identify small molecules that improve function of macrophages. This requisition is to procure a a set of edited iPSC and THP1 cell lines, with subsequent isolation and expansion from a single cell (clonal population) that can be used to differentiate into macrophages. The experimental procedure has been optimized for use with the 802-30F cell line and THP1 (engineered and procured previously from Synthego). Additionally, several edits to the genome have already been made by Synthego, and the procedures for working with these cells have been extensively characterized and validated. Purchasing an alternate would require re-engineering of the cell line and re-optimization of the experimental procedure, both of which would require substantial cost of effort and time The essential characteristics the edited human cell lines that limit the availability to a sole source are capacity to perform genome edits for 802-30F iPSC and THP1 cells carrying HiBit at CD63 locus. This essentially require a knock-in small insertion of HiBit tag in complex genomic regions such that CD63, which will result in a luminicent tag that can be used in high-throughput screening. We are currently using sister cell lines that were engineered by Sythego and this purchase order will result in additional reagents that can be utilized following procedures that have been extensitvely optimized and allow for experimental comparisons to be performed, as they will be derived from the same lineage The supplier will bank pooled population, and there will be possibility to isolated single clone in future, in case of need. Substituting an alternative product would require significant experimental reoptimization and cost (time and reagents). Furthermore, the cell line lineage from a different provider would not be identical, which could lead to inability to interpret experimental data. The intended source is: Synthego Corp 3696 Haven Ave, Suite A - Redwood City, CA 94063 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. 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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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. 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 Unique Entity ID (UEI), 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 the closing date and time of this announcement and must reference the solicitation number 75N95023Q00628. Responses must be submitted electronically to Giuliana Faller, Contract Specialist, at giuliana.faller@nih.gov. U.S. Mail and fax responses will not be accepted.