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This Statement of Work (SOW) details a contract for the National Institute on Aging (NIA) to generate genetically engineered induced pluripotent stem cell (iPSC) lines for Alzheimer's disease and related dementias research. The contractor will develop up to 230 isogenic cell lines with 70 WT-ALFAtag projects and 160 SNV-ALFAtag projects, using the KOLF2.1J cell line and Amaxa4D nucleofection system. Each clone will undergo extensive quality control, including Sanger sequencing, antibody staining, imaging on an OperaPhoenix system, mycoplasma testing, long-read sequencing, and array-based genotyping in a CLIA-certified laboratory.

The contract period runs from September 30, 2025 to September 29, 2026, with the contractor required to provide dedicated laboratory staff and a computational scientist. Deliverables include expanded and archived clones in quadruplicate 96-well storage plates, with one lead clone identified and sent to the contractor's facility for scientific community distribution. A comprehensive final report must document the engineering methods, sequencing results, genotyping, imaging validation, and SNP array results for each iPSC line. The government will provide the list of selected mutations for cell line engineering, and no travel is required for the contractor's employees.

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Other files

File Type Posted
FAR 52.212-5 (Jan 2025).pdf PDF
FAR 52.204-26 (Oct 2020).pdf PDF
SBCX Industry Subcontracting Guide.pdf PDF
HHSAR 352.239-79 Feb 2024.pdf PDF
HHSAR 352.239-78 Feb 2024.pdf PDF
FAR 52.204-24 (Nov 2021).pdf PDF
Invoicing Instructions.pdf PDF

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Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK

GENERAL INFORMATION

Title of Project:

iNDI ALFAtag cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project

Statement of Need and Purpose:

The National Institute on Aging (NIA) requires a contractor to generate a collection of up to 230 isogenic Alzheimer's disease and related dementias (ADRD) iPSC cell lines harboring a WT- ALFAtag or SNV-ALFAtag in the KOLF2.1J cell line.

Background Information and Objective:

Contractor shall provide genetically engineered iPSCs for the purpose of creating a national cell repository as an open resource for the scientific community and as a tool to characterize how mutations change fundamental biological properties of disease-relevant cell types. These lines will harbor a fluorescent ALFAtag to visualize the tag and single nucleotide alleles through microscopy approaches. The cell line development and QC reporting must be consistent with other project data that has been collected from the iNDI project so far.

Period of Performance:

September 30, 2025- September 29, 2026

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

Specific Requirements:

3-6 independent heterozygous clones will be recovered for each project and screened to identify the candidate lead clone. The Contractor shall target the below numbers for each cell type:

- 70 WT-ALFAtag projects

- 160 SNV-ALFAtag projects Platforms used by the contractor must include:

Amaxa4D nucleofection system to facilitate editing human iPSCs.

The contractor shall also provide QC results on all engineered clones that will include Sanger sequencing, imaging validation via antibody staining and imaging on an OperaPhoenix system, mycoplasma testing, long read sequencing, and array-based

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs genotyping using a high-density Illumina SNP arrays in a CLIA-certified laboratory.

Where appropriate, on-target analysis by PCR and sequencing should be performed and results reported. All data must be compatible with existing iNDI cell line data.

To accomplish these requirements, the Contractor shall provide dedicated laboratory staff to develop cell lines and also a computational scientist to analyze the data.

The contractor shall provide clones after engineering and QC/QA information that includes the description of genetic modification and associated IDs, primer sequences for genotyping, quality control data (Sanger sequence traces of the edited allele and results of karyotype and array analysis).

GOVERNMENT RESPONSIBILITIES

The government will provide a list of selected mutations to vendor for cell line engineering.

DELIVERY OR DELIVERABLES

Each clone shall be expanded and archived in quadruplicate 96-well Matrix™ storage plates each containing 8 vials of the heterozygous clone. One lead clone will be identified that is verified by the below QC measures. A copy of the lead cell line should be sent to the contractor’s facility for distribution to the scientific community.

REPORTING REQUIREMENTS

The contractor shall provide a one time report at the end of the period of performance documenting:

a. General method of engineering employed for each line, including information about the nuclease used and protein/plasmid based delivery (e.g. WT spCas9 RNP, TALENs, plasmid-based CRISPR, etc)

b. Sanger sequencing for each iPSC line

c. Next Generation sequencing results for each line

d. cDNA genotyping for each line

e. Imaging validation on an OperaPheonix system for each iPSC line

f. SNP Array results from a CLIA-certified laboratory for each iPSC line

OTHER CONSIDERATIONS

Travel:

The principal place of performance is the contractor’s work site. Travel for contractor employees will not be necessary.

Key Personnel:

The contractor shall provide a dedicated project manager to the government as a point of contact for the services.

SCOPE OF WORK
DELIVERY OR DELIVERABLES

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