SAM_-_Pre-Solicitation__6992497_1.pdf

75N94024Q00209

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A

CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.

The National Institutes of Health, National Institute of Child Health and Development (NICHD) intends to award a purchase order without providing for full and open competition to CYAGEN BIOMODELS LLC for Turboknockout Gene Targeting Services in support of NICHD Mammalian Hematopoietic System Research.

BACKGROUND

Our research focuses on the development of the mammalian hematopoietic system. A long-term area of interest for our laboratory is the study of signal transduction molecules and pathways that regulate T lymphocyte maturation in the thymus. Currently, we are analyzing transgenic and conditional nonsignaling mutants of T cell antigen receptor (TCR) signaling subunits to evaluate the importance of individual TCR signaling chains and motifs at specific stages of T cell development and in mature T cells. We are also using gene profiling to identify proteins that are important for fine-tuning the T cell–signaling response in developing and mature T lymphocytes. In conjunction with checkpoint inhibitors for immunotherapy in humans, these molecules may also be targets. We are also investigating the function of new T cell–specific proteins that we identified by subtraction library screening. We have identified the CD3delta/gamma genes that we need to make conditional knockin/knockout mouse models of for future investigation. CD3delta/gamma is involved in the T cell singling receptor pathways and is part of our ongoing Themis 1 & 2 and 6Y/6F projects, respectively, in the lab.

JUSTIFICATION

The needed services allow for the generation of conditional knock-in/out mouse models, though ES targeting cell lines, in 6-8 months instead of the conventional 10-14 months. Based on market research results, Cyagen is the only company that is capable of providing this unique TurboKnockout ES cell targeting conditional knock-in/out mouse model generation service. The shorter turnaround time compared to conventional standards is very important for the lab because it allows us to move the research in a timelier manner. We need to know the results sooner, than later, so that we can make decisions on how to proceed with future research. Also, these scientific projects are assigned to research training candidates (i.e. post-baccalaurean, post-doctoral), who have limited time in the lab. It is most advantageous for these staff members and our lab to have the mouse models as soon as possible so that they can start on their research projects. Also, we are currently using multiple mouse models generated previously from Cyagen and we find that they knock-in the gene of interest in the correct spot and orientation (compared to other companies/services where we had to backtrack and trace where the gene went). Every single mouse line that we currently have, made by Cyagen, expresses the gene of interest. They also performs and provides a complete genotyping regiment to identify the gene of interest that have different knock-in variations of the CD3 gene of interest so this mouse line with this new variation of the CD3 gene would be a continuation of the ongoing CD3 project. If we went with another

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

company, it would introduce a new variable because another company would not be able to make the mouse model in the same way as Cyagen would, therefore we need to continue services with Cyagen to maintain continuity of our research. A switch to an alternative vendor/service now would introduce a new variable into the CD3 project because we currently have live animals that have different knock-in variations of the CD3 gene made by Cyagen in our animal facility. We want to compare these previously made CD3 knock-in variations to this new CD3 knock-in variation. It is very important to have these mice made in the same way (through the TurboKnockout ES cells exclusive to Cyagen), so that we can compare the different CD3 knock-in variations.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 with a Size standards in millions of dollars: $19.0.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2024-05 effective 05/22/2024. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000) and FAR Subpart 12- Acquisition of Commercial Items.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of FAR 13.106(b)(1) Soliciting from a single source - For purchases not exceeding the simplified acquisition threshold.

PLACE OF DELIVERY

NIH/NICHD

BG 6B RM 2B210

9000 Rockville Pike Bethesda, MD 20892

DESCRIPTION OF REQUIREMENT

We need the following TurboKnockout gene targeting services. For conditional knockin/out, we will be able to breed founders directly to our tissue-specific Cre mice, which allows us to advance our research much more quickly than conventional knock-out generation. Services include analyzing the gene of interest. Then developing a targeting strategy which would be reviewed and approved by the lab. Once approved, services will include construction of the TurboKnockout targeting vector, where relevant DNA fragments will be cloned into the targeting vector and the correct construction confirmed by restriction digest and sequencing. The targeting vector is then electroporated into the super competent TurboKnockout ES cells, followed by drug selection and isolation of drug-resistent clones. The ES cell clones are then screened by PCR and up to six positive clones are expanded and confirmed by Southern blot. These ES clones are karyotyped to ensure correct chromosome number and then introduced into mouse host embryos, followed by transfer into surrogate mothers. The resulting mice are 100% derived from the injected ES cells and are confirmed by PCR. Once confirmed, the mice (minimum of 3) are shipped to us.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability in response to this notice and may submit a capability statement, which shall be considered by the agency. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement.

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 respondents must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses to this notice shall be submitted electronically by 6:00 PM Eastern Standard Time, on 8/9/2024 to jacob.balenson@nih.gov and shall include pre-solicitation # 75N94024Q00209 in the subject line.

http://www.sam.gov/ mailto:jacob.balenson@nih.gov