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Solicitation Number: 75N95025Q00209-SBSS Title: iNDI FA13.1J cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project This is a Small Business Sources Sought notice. This is NOT a sol... Solicitation Number: 75N95025Q00209-SBSS Title: iNDI FA13.1J cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is being issued to help determine the availability of qualified companies technically capable of meeting Government requirements and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Institutes of Health (NIH) Intramural Center for Alzheimer’s and Related Dementias (CARD) is a collaborative initiative of the National Institute on Aging (NIA) and National Institute of Neurological Disorders and Stroke (NINDS) that supports basic, translational, and clinical research on Alzheimer’s disease and related dementias. CARD’s central mission is to initiate, stimulate, accelerate, and support research that will lead to the development of improved treatments and preventions for these diseases. Understanding the molecular signature of the human brain is essential to study pathogenesis of neurodegenerative diseases. The Induced Pluripotent Stem Cell (iPSC) Neurodegenerative Disease Initiative (iNDI) is a comprehensive genome engineering project. iNDI researchers are engineering more variants associated with Alzheimer’s and related dementias into cell models of disease. The project, embedded within CARD, was established to apply genomic engineered iPSC-derived neuron models to the field of Alzheimer’s disease and related dementias (ADRD) research. The long-term, large-scale project demands well-validated pipelines to counter risks of outcome reliability and consistency, as well as maximizing throughput when dealing with a large number of cell lines. Purpose and Objectives: The purpose of this acquisition is to generate a collection of up to 936 isogenic Alzheimer's disease and related dementias (ADRD) iPSC cell lines. Description: The Contractor shall provide genetically engineered iPSCs to ser as a tool to characterize how mutations change fundamental biological properties of disease-relevant cell types. Specific Requirements: Project Deliverables Gene-edited iPSC lines shall be expanded and QC’d aligned with the current iNDI cell line protocols using CRISPR-Cas12a technology. Once distribution lots have passed QC they shall be made available for purchase to the scientific community. FA13.1J female SNV lines (162 trios) totaling 486 iPSC lines (Appendix A) 25 of the most relevant SNVs (trios) across six additional iPSC lines totaling 450 iPSC lines (Appendix B), enabling researchers to assess reproducibility across diverse genetic and APOE backgrounds Production Lot Expansion (n=40 vials) in accordance with the current iNDI cell line protocols. Production Lot QC: shall include viability testing with Trypan blue with a threshold of >80%, non-viral agent panel testing via qPCR, viral (DNA) panel testing via qPCR, viral (RNA) panel testing via qPCR, yeast and fungal testing via inoculation and aerobic culture for 10 days, gram-negative bacterial testing via inoculation and aerobic culture for 48 hours, gram-positive bacterial testing via inoculation and aerobic culture for 48 hours, gene-edited variant sequence confirmation via PCR and Sanger sequencing of wild type and variant alleles from distribution lots. N=32 shall be made available for sale and n=7 shall be held for low passage inventory replenishment Product & Web Content Creation: Shall include all QC data and design files shall be curated and uploaded to the website creating product pages for each iPSC line Key Personnel: To accomplish these requirements, the Contractor shall provide a dedicated senior PhD accredited project manager to develop cell lines. GOVERNMENT RESPONSIBILITIES The government will provide a list of selected mutations to the vendor for cell line engineering. DELIVERY OR DELIVERABLES For each engineered iPSC project, two or more independent clones will be expanded and archived in quadruplicate 96-well Matrix™ storage plates each containing 8 vials per clone of up to 6 clones per project. Two of the quadruplicate 96-well Matrix plates (i.e., two copies of the resource) will be sent to the NIH or to NIH-designated repositories. REPORTING REQUIREMENTS After completion of the expansion and QC, the contractor shall provide a one-time report for each cell line documenting: General methods of engineering employed for each line, including information about the nuclease used and protein/plasmid-based delivery (e.g. WT Cas12a RNP, TALENs, plasmid-based CRISPR, etc) Gene-edited variant sequence confirmation via PCR and Sanger sequencing of wild type and variant alleles from distribution lots Viability testing Non-viral agent panel testing Viral (DNA) panel testing Viral (RNA) panel testing Yeast and fungal testing Gram-negative bacterial testing Gram-positive bacterial testing Other important considerations: The principal place of performance is the vendor’s work site. Travel for contractor employees will not be necessary. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. All capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Iris Merscher, Contract Specialist, at e-mail address iris.merscher@nih.gov and NIDA Office of Acquisition at nidacoaccommunications@nida.nih.gov. The response must be received on or before July 24, 2025, at 5PM, Eastern Time. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).