SOW_Cryopreserved_No-Spin_HepaRG.pdf

STATEMENT OF WORK

CRYOPRESERVED NO-SPIN HEPARG (8M CELLS/VIAL)

NATIONAL INSTITUTES OF ENVIRONMENTAL HEALTH SCIENCES

RESEARCH TRIANGLE PARK, NC

1.0. BACKGROUND: The National Institute of Environmental Health Sciences (NIEHS), located in Research Triangle

Park, North Carolina, is one (1) of 27 research institutes and centers that comprise the National Institutes of Health (NIH), U.S. Department of Health and Human Services (DHHS). The mission of the NIEHS is to discover how the environment affects people in order to promote healthier lives. The National Toxicology Program Division (DNTP) oversees and carries out the activities of the National Toxicology Program. The Biomolecular Screening Branch (BSB) falls under the DNTP and develops and carries out programs in medium and high throughput screening of environmental substances for rapid detection of biological activities of significance to toxicology. Branch scientists at the BSB strive to improve the relevance of assay findings to human health outcomes, providing data from a variety of high throughput and/or high content approaches and developing computational approaches to best analyze those data. The BSB requires up to 400 vials of cryopreserved No-Spin HepaRG cells containing 8 million cells per vial for a large toxicology screening project which is being performed in collaboration with the Environmental Protection Agency (EPA). These cells support primary human hepatocyte-like cell functionality, and are emerging as models to screen chemicals for hepatotoxicity and drug-induced liver injury. More specifically, the request is for No-Spin HepaRG manufactured by Biopredic International. The No-Spin

HepaRG is trademarked & the cells are cryopreserved after differentiation using a proprietary process developed by

Biopredic. The cryopreserved No-Spin HepaRG is a fully-functional, adult-phenotype, human hepatic cell line that does not require centrifugation. The HepaRG are renewable and reproducible hepatic cells derived from a single donor which possess the unique capabilities of being grown to increase their population, but can also be differentiated into fully-functional, adult phenotype hepatic cells. The cryopreserved No-Spin HepaRG cells simply require only thawing prior to use. All other forms of cryopreserved hepatocytes require thawing, suspension, centrifugation, resuspension, and cell counting steps. The No-

Spin HepaRG is provided in a convenient, terminally differentiated, cryopreserved format that does not require the user to centrifuge, resuspend, or count the cells after thawing. This eliminates multiple steps that introduce qualitative and quantitative variability and reduces the time and effort needed to perform an assay. The No-Spin HepaRG version is required due to its qualified simplicity of use that would need to be optimized if any other cell is used. As such, the intent here is not to use any other substitute that requires using alternate protocols.

2.0. OBJECTIVE: The basic objective is to provide 400 vials of cryopreserved No-Spin HepaRG (8.0 million cells/vial).

3.0. ITEM SPECIFICATIONS: The Contractor shall ensure the item complies with the description in 1.0 above and in 3.0 below:

• Allow for direct thawing and seeding of cryopreserved differentiated cells without the need for post-thaw washing, counting and centrifugation steps;

• Form a co-culture of hepatocytes and biliary epithelial-like cells a few days after thawing and seeding;

• Be able to be used directly for plating and/or suspension without washing, sedimentation, decantation, centrifugation, and/or counting when the cell product is thawed;

• Consist of a concentrated composition of cryopreserved cells (a first amount of cells and a freezing solution comprising a cryoprotectant dispersed in medium or carrier solution);

• Be the No-Spin HepaRG and must simply require only thawing prior to use/must not require alternate protocols

(i.e., suspension, centrifugation, resuspension, and cell counting steps); and

• Be provided in a convenient, terminally differentiated, cryopreserved format that does not require the user to centrifuge, resuspend, or count the cells after thawing

• Delivery within 3 to 4 weeks after receipt of order

• Shipping to NIEHS

• Proper packaging so that item arrives intact.

4.0. DELIVERY POC/LOCATION: Stephen Ferguson, Ph.D. Tel 984-287-3128/BSB/DNTP, Building 105, T.W.

Alexander Drive, Research Triangle Park, North Carolina 27709.