SOW Generate Alzheimers Disease and Related Dementia ADRD patient-derived iPSC lines.pdf
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- SOURCES SOUGHT: Generate Alzheimer’s Disease and Related Dementia (ADRD) patient-derived iPSC lines
- Solicitation number
- 75N95022Q00098
About this file
This sources sought notice requests capability statements from small businesses for a contract to generate up to 200 induced pluripotent stem cell lines from patient samples. The National Institute on Aging seeks a contractor to reprogram blood or blood component samples using Sendai virus and perform quality control testing, including sterility, mycoplasma, pluripotency marker expression, differentiation potential, identity testing, and viability. The contractor will deliver six bank vials of each monoclonal line to the government. Responses are due by February 8, 2022 and should identify the business as a small, small disadvantaged, 8(a), HUBZone, service-disabled veteran-owned, veteran-owned, or woman-owned small business and provide capability statements demonstrating compliance with requirements within the July 1, 2022 to June 30, 2024 period of performance. The anticipated award is a small business set-aside issued by the National Institutes of Health National Institute on Drug Abuse.
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Text version
STATEMENT OF WORK
GENERAL INFORMATION
Title of Project:
Generate Alzheimer’s Disease and Related Dementia (ADRD) patient-derived iPSC lines
Statement of Need and Purpose:
To generate a collection of up to 200 engineered induced pluripotent stem cell lines from human patient fresh whole blood or peripheral blood mononuclear cells (PBMCs).
Background Information and Objective:
Contractor to 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.
Period of Performance:
Base year: July 1, 2022 - June 30, 2023 Option year 1: July 1, 2023 - June 30, 2024
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:
Contractor shall generate a collection of up to 200 engineered iPSC lines from fresh whole blood or frozen PBMCs using Sendai virus reprogramming methods. Upon receiving samples, the Contractor shall perform viability, mycoplasma, and sterility on samples. Samples that show negative results following quality control will undergo reprogramming.
Following reprogramming, the vendor shall perform a pluripotency expression profile to check that cells express markers of pluripotency without early differentiation markers. Cells that pass this analysis will then undergo sorting and consolidation and expansion. All lines with be QC’ed after sorting and consolidation and expansion phases. Finally, the cells will be QC’ed to ensure that they lack sendai transgene expression (using Nanostring Gene Expression Analysis) and can differentiate into the three germ layers (using a Nanostring 3 Germ Layer Scorecard Analysis).
Lines that pass these analyses, sterility testing, mycoplasma testing, pluripotency testing, viability testing, and identity testing shall be delivered to the Government in 6 bank vials.
LEVEL OF EFFORT:
Vendor staff will provide the line generation and QC results via reporting through email.
GOVERNMENT RESPONSIBILITIES
The government will provide fresh whole blood or frozen PBMC starting material to vendor.
DELIVERY OR DELIVERABLES
Six (6) master bank vials of a monoclonal iPSC line from each starting PBMC or whole blood sample of approximately 500,000-1,000,000 cells/vial.
REPORTING REQUIREMENTS
The vendor is to provide documentation regarding:
a. General method of engineering employed for each line
b. Certificate of Analysis of quality control results for each line.
OTHER CONSIDERATIONS
Travel:
The principal place of performance is the vendor’s work site. Travel for contractor employees will not be necessary.
Key Personnel:
Vendor shall provide a dedicated project manager to the government as a point of contact for the services.
Information System Security Plan:
Not Applicable
Data Rights:
Section 508—Electronic and Information Technology Standards:
The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.
Publications and Publicity:
Confidentiality of Information:
File details come from the government source that posted it. Updated .