Attachment 1 - Purchase Description.pdf

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

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: This requisition is to purchase a set of stability

(environmental) chambers for the Formulation Lab within the Therapeutic Development

Branch (TDB), under the Division of Preclinical Innovation (DPI) at NCATS.

2. Background Information and Objective:

The National Center for Advancing Translational Sciences (NCATS), a component of the

National Institutes of Health, aims 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.

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 Division of Preclinical Innovation (DPI), Therapeutic Development Branch (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 open 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.

A formulation laboratory requires stability (environmental) chambers to control and maintain specific stability conditions such as temperature, humidity, light, and air quality.

These chambers provide a stable and controlled environment to perform experiments and develop formulations that require specific stability conditions. Additionally, stability

(environmental) chambers can be used to test the stability of formulations under different stability conditions. By exposing the formulations to various temperature and humidity conditions, the laboratory can determine how the product will perform under real-world conditions, and make necessary adjustments to the formulation to improve its stability.

NCATS intends to procure total eight (8) stability (environmental) chambers from the same vendor to furnish our stability suite in the formulation lab for the following reasons:

1. Compatibility: When buy all stability (environmental) chambers from the same vendor, we can ensure that they are all compatible with each other. This means that we can integrate them seamlessly into laboratory and avoid compatibility issues that may arise if purchase chambers from different vendors.

2. Consistency: Using chambers from the same vendor can help ensure consistency in terms of performance, maintenance, and repair. This can help streamline laboratory processes and reduce the risk of errors or inconsistencies in experiments.

3. Support: When purchase all stability (environmental) chambers from the same vendor, we can benefit from the vendor's support and service offerings. This can include technical support, repair services, and access to spare parts, which can help ensure that chambers remain in optimal condition over time.

4. Cost savings: Buying all stability (environmental) chambers from the same vendor can also help save money on the purchase price, as well as on maintenance and repair costs. Many vendors offer discounts for bulk purchases, and we may also be able to negotiate better pricing for ongoing service and support.

Given the number of different stability (environmental) chambers needed, NCATS prefers to order from one manufacturer for greater cost savings, ease of maintenance, and required services.

3. Generic Name of Product: Stability (Environmental) Chambers

4. Purchase Description:

This requirement is for Brand Name or Equal products. The following are the needed equipment and their salient characteristics:

1. Thermo Scientific TSX Series High-Performance Refrigerator or Equal

Product number: TSX2305GA

Quantity: 1

a. Support sample protection and sustainability objectives for the storage of media, reagents, chemotherapy, pharmaceutical and other medical and laboratory-grade storage requiring 2° to 8°C.

b. Over 450W of reserve refrigeration capacity

c. Power to protect products from temperature swings as a result of frequent and prolonged door access

d. Large product loads, and other activities that introduce heat to the cabinet.

2. Thermo Scientific TSX Series High-Performance -20 deg.C Manual Defrost

Freezer or Equal

Product number: TSX2320FA

Quantity: 2

a. Dimensions Interior: 28.5 x 24 x 58 in

b. Advanced insulation and refrigeration technologies to minimize energy consumption

c. Provides visual and audible alarms in the event of temperature deviations

d. The freezer has an advanced monitoring system that tracks and records temperature and other critical parameters, allowing for remote monitoring and real-time data analysis

e. Rugged design that can withstand the demands of a laboratory environment

f. The freezer is equipped with a locking door and adjustable shelving to provide secure and efficient sample storage

3. Thermo Scientific Forma Vertical Light Chamber Light or Equal

Product number: 15500201

Quantity: 1

a. Capacity: 821 L, 29 cu.ft.

b. Stainless Steel Type 304/1.4301, 2B Finish

c. Cold-rolled steel, powder-coated cabinet

4. Thermo Scientific Forma Vertical Light Chambers or Equal

Product number: 15500208

Quantity: 2

a. Met ICH guideline Q1B

b. Stainless Steel Type 304

5. Thermo Scientific Light/UV Protection for Operator or Equal

Product number: NC2165325

Quantity: 1

a. On/Off Switch for Light Chamber door

b. Automatic

c. Factory installation

d. ICH compliant

6. Thermo Scientific Forma Stability (Environmental) Chambers, Model 3940 or

Equal

Product number: 13067066

Quantity: 3

a. Capacity 29 cu. Ft., 821.2 L

b. Stainless Steel, powder-coated Cold Rolled Steel

c. Humidity control: Ambient to 95% at 37 degrees C

d. Temperature Range: 0 degrees C to 60 degrees C

7. Thermo Scientific Forma Stability (Environmental) Chambers, Model 3920 or

Product number: 13262340

Quantity: 1

a. Capacity: 29 cu. ft., 821.2 L

b. Stainless Steel, Powder-coated Cold Rolled Steel

c. Relative Humidity: Ambient to 95% at 37 deg.C

d. Temperature Range: 0 deg.C to 60 deg.C

8. Thermo Scientific Forma 3960 Series Stability (Environmental) Chambers or

Product number: 03395580

Quantity: 1

a. Capacity: 821.2 L

b. Stainless Steel, Type 304, 2B, Powder-coated Cold Rolled Steel

c. Temperature Range: Ambient +5 deg.C to 60 deg.C

5. Delivery Date: Within 6 months after receipt of order

6. Delivery Address: The NCATS DPI TDB Formulation Laboratory is under construction.

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

FOB 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).

7. Period of Performance: One (1) twelve (12) month period including manufacturer's warranty to begin after completion of instrument installation

8. Option(s): None