D-Attachment-SOW Generate Alzheimers Disease and Related Dementia ADRD patient derived iPSC lines.pdf
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- Solicitation number
- 75N95022Q00098
About this file
This document contains a statement of work and solicitation for a firm fixed-price contract to generate Alzheimer's Disease and Related Dementia patient-derived induced pluripotent stem cell lines. The National Institutes of Health National Institute on Drug Abuse requires a contractor to generate up to 200 engineered iPSC lines from human patient fresh whole blood or frozen peripheral blood mononuclear cells using automated reprogramming methods and perform quality control testing. The base period of performance is July 1, 2022 to June 30, 2023 with an option period of July 1, 2023 to June 30, 2024. Responses are due by April 14, 2022 and must include technical capability, past performance on similar efforts, fully loaded pricing for the base and option years, and registrations in SAM and certifications of business size. Questions are due by April 6, 2022.
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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 an automated system through Sendai virus reprogramming methods. The Contractor shall perform viability, mycoplasma (using Lonza MycoAlert Plus), and sterility (using SteriTEQ) on samples. Samples that show negative results following quality control will undergo reprogramming. Additional QC shall include karyotype analysis (with an Illumina Infinium Global Screening Array-24) and identity testing (Fludigm SNPTrace Panel).
Following reprogramming, the vendor shall perform a pluripotency expression profile to check that cells express markers of pluripotency without early differentiation markers using a Nanostring Pluripotency scorecard analysis. Cells that pass this analysis will then undergo sorting and consolidation and expansion. All lines shall be QC’ed after sorting and consolidation and expansion phases. Finally, the cells shall 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 10 bank vials containing 500,000- 1,000,000 cells per vial. Upon request, the Contractor shall provide the raw QC data to the Government in addition to summary QC results.
The working banks of iPSCs shall be developed within 6-9 months after receipt of PBMCs with batch runs initiated continuously over several months.
LEVEL OF EFFORT:
Vendor staff shall 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
Ten (10) 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 Contractor 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 Contractor’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:
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