D. Attachment 1 - Purchase Description_Final.pdf

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

PURCHASE DESCRIPTION

1. Statement of Need and Purpose:

The purpose of this requisition is to procure FCDI iCell neurons and required supplements to generate 2D and 3D neuronal culture plates to use in neurotoxicity screening assays to complete Milestone 3 for the Roche ASO toxicity collaborative project.

2. Background Information and Objective:

The Therapeutic Development Branch (TBD) within the National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) collaborative project with Roche is aimed at developing assays for predictive toxicity of antisense oligonucleotides (ASOs). 2D and 3D cultures using human induced pluripotent stem cell (hiPSC)-derived neurons (from non-fetal tissue source) have been adapted and extensively optimized by NCATS scientist to successfully predict neurotoxicity of ASOs.

Following successful completion of Milestone 2 testing ASOs with intermediate toxicities, the procurement of additional hiPSC cells is needed to begin Milestone 3 of this project.

Neuronal spheroids generated in 384-well plates using a mixture of astrocytes, GABA, and either Gluta or Dopa ihPSC-derived neurons have been used to mimic the spontaneous activity of the prefrontal cortex and ventral tegmental area. Calcium imaging of these 3D cultures is used in high throughput testing of ASOs and is typically used as the primary screening assay. 2D ihPSC-derived spinal motor neurons co-cultured with astrocytes on 48-well microelectrode array (MEA) plates allows spontaneous electrical activity to be measured over the course of the culture. Changes in neuronal firing following ASO treatment can be quantified to determine neurotoxicity and is typically used as a secondary screen for hits detected with 3D cultures.

Previous optimization of both neuronal 2D and 3D cultures have established the optimal number of neurons for both types of cultures to screen ASOs for neurotoxicity and have been used to successful complete Milestone 2 of this project. In order to complete the Roche project, enough hiPSC neurons and supplements for Milestone 3 2D and 3D culture plates are needed and is a requirement to meet the goals of this project.

3. Generic Name of Product:

Cryopreserved human iPSC derived neurons and supplements

4. Purchase Description:

Trade name: iPSC Astrocyte Kit Brand name: iCell Astrocytes Kit Manufacture: FCDI Model: Kit, Donor 01434, 1 Vial: ≥ 1 x 10^6 cells/vial

Trade name: iPSC Dopaminergic neuron kit Brand name: iCell DopaNeurons Kit Manufacture: FCDI Model: Kit, Donor 01279, 1 Vial: ≥ 5 x 10^6 cells/vial

Trade name: iPSC Gabaergic neuron Kit Brand name: iCell GABANeurons Kit Manufacture: FCDI Model: Kit, Donor 01279, 1 Vial: ≥ 4 x 10^6 cells/vial

Trade name: iPSC Glutamatergic neuron kit Brand name: iCell GlutaNeurons Kit Manufacture: FCDI Model: Kit, Donor 01279, 1 Vial: ≥ 6 x 10^6 cells/vial

Trade name: iPSC Motor Neuron Kit Brand name: iCell Motor Neurons Kit Manufacturer: FCDI Model: Kit, Donor 01279, 1 Vial: ≥ 3 x 10^6 cells/vial

Trade name: Growth factor supplement for neuronal cell types Brand name: iCell Nervous System Supplement Manufacturer: FCDI Model: NA

Trade name: Neuronal medium supplement, serum-free Brand name: iCell Neural Supplement A Manufacturer: FCDI Model: NA

Trade name: Neuronal medium supplement, serum-free Brand name: iCell Neural Supplement B Manufacturer: FCDI Model: NA

5. Salient characteristics iPSCs that are derived from the same patient as cells used in other assays reduces the impact of genetic diversity on assay variability.

6. Quantity:

(30) iCell Astrocytes Kit

(8) iCell DopaNeurons Kit

(4) iCell GABANeurons Kit

(4) iCell GlutaNeurons Kit

(12) iCell Motor Neurons Kit

(24) iCell Nervous System Supplement

(4) iCell Neural Supplement A

(20) iCell Neural Supplement B

7. Delivery Date:

6 Weeks ARO (After Receipt of Order)

8. Period of Performance:

N/A

9. Option(s):

N/A