D Attachment 1 Purchase Description.pdf

FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

Moisture and density system with accessories, training, 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 Mettler Toledo moisture and density system composed of Density meter Excellence D4 and Robust Coulometric Karl Fischer Titrator Compact C30SX with accessories, training, 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 density meter, also known as a densitometer or specific gravity meter, is a device used to measure the density of a liquid or a gas. In a formulation lab, a density meter is an important tool that can provide valuable information about the physical properties of the materials being used in a formulation.

Here are some reasons why having a density meter in a formulation lab is important:

1. Quality Control: A density meter is an essential tool for ensuring the quality and consistency of a product. By measuring the density of the materials used in a formulation, you can ensure that the correct amount of each ingredient is being used and that the final product meets the desired specifications.

2. Formulation Optimization: Density measurements can provide insight into the behavior of different ingredients and how they interact with each other. By analyzing density data, you can optimize the formulation of a product to achieve the desired physical properties.

3. Cost Reduction: A density meter can help reduce costs by enabling you to accurately measure the amount of each ingredient needed for a formulation. By minimizing waste and ensuring accurate measurements, you can reduce production costs and improve efficiency.

4. Regulatory Compliance: Many industries, such as food and beverage, pharmaceuticals, and chemicals, are subject to strict regulations regarding product quality and consistency. A density meter can help ensure compliance with these regulations by providing accurate and consistent measurements.

A Robust Coulometric Karl Fischer Titrator is a laboratory instrument used to determine the water content in a substance. In a formulation lab, a Karl Fischer titrator is an important tool for several reasons:

1. Accurate Moisture Content Measurement: A Karl Fischer titrator can accurately measure the water content in a substance, which is critical in determining the stability and quality of a formulation. Precise moisture content measurements are necessary for ensuring the desired properties and shelf-life of the final product.

2. Versatility: Karl Fischer titrators can be used to analyze a wide range of materials, including solids, liquids, and gases. This makes it a versatile tool for formulation labs that work with different types of materials.

3. Time and Cost Savings: By accurately determining moisture content, a Karl Fischer titrator can help reduce production time and costs associated with product testing and formulation. This can improve overall efficiency and reduce waste.

4. Compliance: Many industries, such as pharmaceuticals and food and beverage, have strict regulations regarding the moisture content of products. A Karl Fischer titrator can help ensure compliance with these regulations, ensuring the safety and quality of the final product.

By combining the moisture determination capabilities of the Karl Fischer titrator with the density measurement capabilities of the density meter, scientists can obtain a comprehensive characterization of both powders and liquids such as a) how moisture affects the density and overall physical properties of the powder, b) assess the concentration or purity of the liquid, c) evaluate the hygroscopic behavior of the powder and understand its stability or storage requirement. This information is valuable for quality control, research and development, and ensuring the desired physical properties of the tested formulations.

Moreover, a density meter and Karl Fischer titrator system that is integrated and operated by one software improves workflow efficiency, enables seamless data integration and analysis, ensures standardization and consistency, simplifies training and maintenance. The implementation of the same software has the potential to significantly augment the laboratory's research capacity by acquisition of additional instruments for future expansion. All these ultimately would lead to enhance productivity and accelerated research processes.

Thus, NCATS DPI TDB requires a Mettler Toledo moisture and density system composed of Density meter Excellence D4 and Robust Coulometric Karl Fischer Titrator Compact C30SX with accessories, training, and warranty (brand-name or equal) to obtain a comprehensive characterization of both powders and liquids and understand its stability or storage requirement.

3. Generic Name of Product: Moisture and Density system

4. Purchase Description: For reference purposes, the moisture and density system that meets the need of this requirement is the Density meter Excellence D4 and Robust

Coulometric Karl Fischer Titrator Compact C30SX with accessories, training, and warranty, as follows:

Part Number Description QTY

13940050 DENSITY METER EXCELLENCE D4 (or equal) 1

13940055 DRYING PUMP DRYPRO (or equal) 1

30474897 SYRINGE HOLDER DX (or equal) 1

11153250 LICENSE LIQUIPHYSICS RM/DM (or equal) 1

30252662 Mettler Toledo Coulometric Karl Fischer Titrator Compact C30SX (or equal) 1

30407502 InMotion KF Pro Oven Autosampler (10mL) (or equal) 1

30407442 GAS STOP VALVE SV2 (or equal) 1

30804719 GAS REGULATOR KIT KF INMOTION (or equal) 1

30407445 SAMPLE VIAL 10 ML 192/PK (or equal) 1

30407436 SCREW CAP 5/10 ML 228/PK (or equal) 1

30097754 LABX TITRATION EXPRESS (or equal) 1

NC2227832 Training Operation 1

12-month warranty 1

Delivery FOB Destination 1

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

1. Density Meter

a. Measurement range (g/cm³): 0 g/cm3 – 3 g/cm3

b. Accuracy ± (g/cm³): 0.0001 g/cm3

c. Repeatability (g/cm³): 0.00005 g/cm3

d. Resolution (g/cm³): 0.0001 g/cm3

e. Temperature control range: 0 °C – 95 °C

f. Temperature control: Yes

g. Measurement scales: Density, Specific gravity, Alcohol, Acid, API, Sugar, Urea, User-defined concentration. Up to 30 user-defined concentration tables (can be entered as tables or formulas).

2. Drying Pump

a. Silica gel capacity: 340 gr.

b. Automation for Enhanced Workflow: Sampling and cleaning (1 sample)

3. Syringe Holder

4. License RM/DM

5. Karl Fischer Titrator

a. Measurement Range: 1 ppm – 5 %

b. Automation Option(s) InMotion KF Oven

c. Display Full-color 5.7 in VGA, touch screen

d. Drying Pump

6. Autosampler

a. Autosampler compatible with the Karl Fischer Titrator for water determination by the oven extraction technique. Upon heating to the sample-specific temperature, the water evaporates and is transferred into the titration vessel by a stream of dry air or nitrogen.

b. Capable of analyzing up to 24 10mL samples in a single run

c. Temperature Scan

7. Gas Stop Valve

8. Gas Regulator for autosampler

9. 10ml sample vial 192/pk

10. Screw cap 5/10ml 228/pk

11. Software license

a. Full version of the software installed in a local computer

b. Connects the titrator, the autosampler, and density meter

c. Programmed standard operating procedures (SOPs)

12. Training

13. DELIVERY FOB DESTINATION

14. 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 B, Rockville, MD, 20850 between the hours of 8:00 am and 5:00 pm, Eastern Standard Time, Monday through Friday (except on Federal Holidays).