D. A1_Purchase Description.pdf

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

PURCHASE DESCRIPTION

Halo Labs Aura Subvisible Particle Characterization System or Equal (COVID-19 action in support of Antivirals for Pandemic Preparedness)

1. Statement of Need and Purpose:

The National Center for Advancing Translational Sciences (NCATS), Division of Preclinical Innovation (DPI) collaborates with external research partners to discover and develop novel treatments for diverse medical conditions. For this purpose, DPI needs a quantity of one (1) Halo Labs Aura Subvisible Particle Characterization System or equal that is capable of quantitatively measuring and identifying any sub-visible particles in solutions and interpreting whether the compounds of interest are completely dissolved.

2. Background Information and Objective:

NCATS develops novel approaches to improve the process of joining basic science discoveries with initial testing of therapies in humans. Within NCATS, DPI plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum.

New chemical entities / small molecule drug candidates require identification of appropriate solvents before further preclinical (in vitro and in vivo) studies can commence. Developing a solvent system suitable for these studies can be complex and time consuming without first conducting proper solubility screening. The procurement of a Halo Labs Aura Subvisible Particle Characterization System or equal will be used by NCATS researchers and scientists to facilitate solubility screening studies and will significantly reduce the time necessary to find the most suitable solvent systems to initiate preclinical studies in the discovery phase. Moreover, these solubility data also serve as a basis for the development of clinical formulations of advanced therapeutic candidates intended for administration to humans. In addition to small molecules, the scientific instrument will be used to support the development of more complex therapeutic candidates, such as peptides and proteins.

Currently, NCATS relies on external contract service providers to perform these solubility and formulation studies, limiting the throughput of experiments. The objective of this acquisition is to bring key equipment in-house so that NCATS scientists can conduct these studies directly and at higher-throughput, which will result in significant cost savings over time.

Lastly, a Halo Labs Aura Subvisible Particle Characterization System or Equal is immediately needed for NCATS to continue its ongoing COVID-19 research specifically to support the Antivirals for Pandemic Preparedness (APP) project. The APP project aims to continue to study COVID-19 and expand the discovery and development of antiviral therapeutic candidates to treat SARS-CoV-2 and its variants, other coronaviruses, and emerging pathogens with pandemic potential.

3. Generic Name of Product:

Sub-visible Particle Characterization Instrument

4. Purchase Description:

Product’s brand name Manufacturer Catalog Number

Quantity

Aura Subvisible Particle Characterization System

Halo Labs 50-1001 1

5. Salient characteristics:

The salient physical, functional, or performance characteristics that “equal” products must meet are as follows:

1. The system must include high-contrast, high-resolution images using direct illumination and fluorescence.

2. The system must have the ability to discriminate between particles of differing types / origins.

3. The system must have a high-throughput format (minimum of 96-well plates) with short analysis time per sample.

4. The system must have the ability to handle measurements in low sample volumes (at or below 10 microliters).

5. The system must have the ability to resolve a range of particle sizes (from micrometers to millimeters).

6. The system must have a PC workstation with all necessary software for instrument operation and data analysis.

6. Quantity:

One (1) system

7. Warranty:

The Contractor shall warrant that that the Equipment will be free from defects for a period of 12-months from the date of installation, inspection, and acceptance by the Government.

The Contractor must have a dedicated service team. This service team should be able to exchange faulty items with their service stock within a week of the user’s equipment fault.

8. Delivery, Installation and Training Requirements:

The Contractor shall provide an Original Equipment Manufacturer (OEM) certified service technician to perform setup, installation, and an on-site training session for staff members.

The Contractor shall deliver and install the equipment within 90 days after receipt of order (ARO). Delivery must be Freight on Board (FOB) Destination and include inside delivery. The equipment shall be delivered and installed in coordination with NCATS Program Official(s) [to be specified at time of award].

The Contractor shall deliver and install the required equipment to laboratory space in Building B. The equipment shall be delivered and installed between the hours of 8:00 am and 5:00 pm, Eastern Standard Time, Monday through Friday (except on Federal Holidays).

National Center for Advancing Translational Sciences Division of Preclinical Innovation 9800 Medical Center Drive Building B/ Room 1022 Rockville, MD, 20850

On-site training (2 days) must take place within two (2) weeks of equipment installation.

The Contractor must provide training to NCATS staff on the system. This will include:

• Unpacking, assembly, and full build of the manufactured products and produced software.

• Installation of the system components and alignment where suitable.

• Full product training on all products as part of the installation.

• An overview of the operation of the entire system and the supplied software.

• Guidance and advice on the installation of third party (non-manufactured) products supplied by the Contractor, if applicable.

9. Period of Performance:

None

10. Option(s):

None