D1 Purchase Description.pdf

FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

NETZSCH Kinexus Prime Pro+ Rheometer with accessories, installation, and warranty

(Brand-name or equal)

1. Statement of Need and Purpose: The Formulation Lab within Therapeutic Development Branch (TDB), under the Division of Preclinical Innovation (DPI), within the National Center for Advancing Translational Sciences (NCATS) seeks to purchase a NETZSCH Kinexus Prime Pro+ Rheometer with accessories, installation, and warranty (brand-name or equal).

2. Background Information and Objective: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

NCATS is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The NCATS DPI plans and conducts collaborative research projects across the preclinical phases of the translational science spectrum, using both internal and contract resources to advance them.

The goal of the NCATS TDB is to help close the gap between basic research and preclinical testing of new small-molecule and biologic drugs, as well as cell-based and gene therapies. Work spans the entire preclinical development pipeline, including medicinal chemistry, toxicology, formulation, and other studies required to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration

(FDA).

NCATS has become a key partner in the Antiviral Program for Pandemics (APP), a multi-agency initiative that includes National Institute of Allergy and Infectious Diseases (NIAID) and Biomedical Advanced Research and Development Authority (BARDA), to accelerate antiviral development through early discovery and preclinical development of safe and effective oral antivirals. The initial priority for the APP is to develop treatments for SARS-CoV-2 and other coronaviruses, with the program expanding to address other virus families with pandemic potential. NCATS will apply its proficiency in drug discovery and development and its cutting-edge technologies to fill critical needs of the APP, such as (i) target validation, (ii) high-throughput screening (HTS) for drug starting points, (iii) medicinal chemistry for lead optimization, and (iv) preclinical, investigational new drug (IND)-enabling development

Many programs within NCATS enable research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing. One of the focuses of the DPI, TDB, is to partner with researchers to generate preclinical data and clinical-grade material for use in Investigational New Drug (IND) applications to a regulatory authority. To accomplish these goals, a brand-new formulation laboratory dedicated to preclinical research will be opened in the fall of 2023. In the new laboratory, scientists will research formulation and manufacturing processes to optimize products’ composition, dosage form, and delivery system to ensure that they are safe, stable, and effective. Specialized Instruments essential for formulation development include equipment for formulation preparation, analytical assay, and stability studies. Moreover, the newly established formulation laboratory will be responsible for producing small-scale engineering batches of the studied drugs. The expertise and insights gained from these manufacturing processes and analytical tests will be shared with our collaborators to ensure the successful production of high-quality, GMP-compliant formulations suitable for human consumption in clinical trials. Moreover, this system will be used to assist in the formulation development of lead APP candidates and other drug substances into phase I clinical trials.

A rheometer is an analytical instrument used to measure the flow and deformation properties of materials such as fluids, semi-solids, and solids. In a formulation lab, rheometers are important for several reasons:

1. Quality Control: Rheometers can be used to evaluate the quality of raw materials and finished products by testing their viscosity, elasticity, and other physical properties.

2. Formulation Development: Rheometers can help formulation scientists develop new products by providing insights into the flow and deformation properties of different materials and how they interact with each other.

3. Process Optimization: Rheometers can be used to optimize manufacturing processes by providing real-time data on material behavior during processing.

4. Regulatory Compliance: Rheometers can be used to ensure compliance with industry standards and regulations by testing the physical properties of materials according to specific requirements.

Thus, NCATS DPI TDB requires a rotational rheometer to measure the flow and deformation properties of materials such as fluids, semi-solids, and solids in the formulation lab.

3. Generic Name of Product: Rotational rheometer

4. Purchase Description: For reference purposes, the Rotational rheometer that meets the need of this requirement is the NETZSCH Kinexus Prime Pro+ Rheometer with accessories, installation, and warranty (Brand-name or equal), as follows:

Part Number Description QTY

RHR000KIA10.020-

Kinexus Prime pro+ rheometer platform 50N normal force including rSpace software 1

KNX2001-E Mid- Level Kinexus plate environmental controller for temperature control 1

KNX2500 Kinexus passive heat exchanger 1 KNX2028 Upper measuring plate 40mm 1 KNX2027 Upper measuring plate 25mm 1 KNX2026 Upper measuring plate 20mm 1 KNX2036 Upper measuring cone 4°/40mm 1 KNX0113 Interchangeable plate lower pedestal 61mm diameter 1

1.400.69-58.0.00A Computer system 1

KNX2513 Passive solvent trap cover for Standard Plate and Cylinder Cartridges 1

KNX2009 Standard rheometer verification kit 1 SER040009 Installation 1

BA-KINEXUS-DIG Operating instructions 1

DELIVERY FOB DESTINATION 1

12-month warranty after installation 1

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

1. Rotational Rheometer

a. Torque range Viscometry: 5nNm to 225mNm

b. Torque range Oscillation: 1nNm to 225mNm

c. Torque resolution 0.1nNm

d. Motor inertia: 1.2e-5 kgm^2

e. Angular velocity range: 1nrad/s to 500rad/s

f. Step Change in Strain: <10ms

g. Angular resolution: <10nrad

h. Oscillation frequency range: 1ìHz to 150Hz

i. Normal force range 0.001N to 50N

j. Normal force response time <10ms

k. Vertical lift speed range: 0.1ìm/s to 35mm/s

l. Vertical lift range (measurable) : 230mm

m. Gap resolution 0.1ìm

n. Raw instrument variables: 5kHz constant streaming data

o. Software: Site-wide user license, sequence-driven user interface enabling

Standard Operating Procedure (SOP)-type test functionality and fully customizable test designs.

2. Plate environmental controller for temperature control

a. Temperature range with passive heat exchanger: -5 °C to 150 °C

b. Temperature range with refrigerated circulator: -40 °C to 150 °C

3. Passive heat exchanger

a. Heat expansion vessel KNX2278

b. Coolant ZZZ0721

4. Upper Measurement Plates:

a. Stainless steel (316 Grade) – 40mm

b. Stainless steel (316 Grade) – 25mm

c. Stainless steel (316 Grade) – 20mm

5. Stainless steel (316 Grade) Upper Measurement cone 4°/40mm

6. Stainless steel (316 Grade) Interchangeable plate lower pedestal 61mm diameter

7. Computer System

a. Desktop PC, minimum specification:

i. Processor Core i5 or similar,

ii. RAM 16GB, SSD 256 GB, Full-HD-Display min. 23" Ultra VGA,

iii. Windows 10 Professional / 64 bit

iv. Interfaces: USB, Ethernet

v. English Language

8. Stainless steel (316 Grade) solvent trap cover for Standard Plate and Cylinder Cartridges.

9. Standard rheometer verification kit with operation instructions.

10. Installation

11. DELIVERY FOB DESTINATION

12. 12-month warranty after installation

6. Quantity: One (1) of each, as provided in the Purchase Description

7. Delivery Date: The NCATS DPI TDB Formulation Laboratory is under construction.

Therefore, delivery is expected to be performed in September 2023.

Delivery shall be Inside Delivery at Destination to 9808 Medical Center Drive Building E, Rockville, MD, 20850 between the hours of 8:00 am and 5:00 pm, Eastern Standard Time, Monday through Friday (except on Federal Holidays).

6. Installation: Installation shall be performed by personnel authorized by the manufacturer to perform installation activities. The installation shall occur at a date and time scheduled by NCATS, no later than sixty (60) days from delivery.