1-SOW.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Custom P/Q type calcium channel CaV2.1 cell lines

Statement of Need and Purpose:

The purpose of this procurement is the acquisition of custom cell lines that express CaV2.1 calcium channels and kir2 inward rectifier potassium channel for the Therapeutic Development branch at NCATS. We require Codex BioSolutions Inc. to make a custom cell line from HEK293 cells.

Background Information and Objective:

The National Center for Advancing Translational Sciences (NCATS) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers.

Within NCATS, the Therapeutic Development Brand (TDB) works to encourage and speed the development of new treatments for diseases with high-unmet medical needs. This acquisition will specifically address the pathophysiology of diseases arising from mutations in genes that encode Cav2.1, a type of voltage-dependent calcium channel. Mutations in genes encoding the pore forming subunit of these channels lead to different disease phenotypes. As an example, mutations in CACNA1A gene lead to rare diseases with significant neurological disorders such as neurodevelopmental delay, epilepsy, seizures, cerebral atrophy, familial hemiplegic migraines, eye disorders, and ataxia.

TDB requires a custom cell line of human origin (HEK293 cells) that express Cav2.1 with a resting membrane potential of -60mV for the fluorescence calcium dye assay. Codex BioSolutions specializes in cell-based assays and has substantial experience in generating stable cell lines such as the hERG potassium channel cell line for high-throughput screening.

We would like to procure HEK293 cells with stably transfected calcium channel subunits as well as the potassium channel kir2.1 to hold the membrane potential. Codex has a Hamamatsu FDSS fluorescence kinetic plate reader and a proprietary fluorescent calcium dye that can be used to select a correct calcium channel line for the high throughput screening assay that NCATS needs. With the established P/Q type Cav2.1 stable cell line, TDB biology will be able to perform large compound screening to identify both agonists and antagonists against the Cav2.1 channels by utilizing the Hamamatsu FDSS system to monitor calcium activity. Follow-up screens on promising leads can also be performed at NCATS or in concert with collaborators such as the CACANA1 foundation for further drug development.

Period of Performance:

15 weeks after receipt of order

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.

Specific Requirements:

Codex BioSolutions will generate stable a P/Q type calcium channel CaV2.1 cell line by cloning alpha1a, alpha2-delta and beta 1 channel proteins into HEK293 cells. Additionally, Codex will introduce kir2.1, an inward rectifier potassium channel, to the P/Q type calcium channel line which will allow the cell's resting membrane potential to be around −60 mV to control calcium channel opening and closing.

GOVERNMENT RESPONSIBILITIES

N/A.

DELIVERY OR DELIVERABLES

• Codex will provide established P/Q type cav2.1 cell lines (and useful colonies selected from cell line establishing process for backup consideration).

• Codex will provide email updates to NCATS, every 4 weeks, including any technical difficulties encountered, and an assessment of status of the cells.

• Codex will provide a final report consisting of validation of cell generation with the specified requirements as well as any cell performance data upon delivery of cells.

OTHER CONSIDERATIONS

N/A

Key Personnel:

N/A

Information System Security Plan:

Data Rights:

Section 508—Electronic and Information Technology Standards:

N/A

Publications and Publicity:

N/A

Confidentiality of Information: