D. Attachment 1 - Purchase Description.pdf

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

PURCHASE DESCRIPTION

Multiple formulation related laboratory tools and equipment. This is a COVID-19 requirement. List include:

Microscope interface

Ultrasonic Cleaning Bath Accessory

Decapper Plier

Flame Resistant Cabinet

13 mm Crimp Vials

20 mm Crimp Vials

Paddle Stirrer

Hotplate 7x7

Ultrasonic Cleaning Bath

Hotplate 10x10

Digital camera for the microscope

Powered crimping/decapping tool

Extruder set

Upright microscope

Overhead stirrer

Peristalitic pumps

LRS for Flammable storage cabinet

Tapped Density

Vortex mixer

1. Statement of Need and Purpose: This requisition is to purchase Multiple small formulation related laboratory tools and equipment for the Formulation Lab within the Therapeutic Development Branch (TDB), under the Division of Preclinical Innovation (DPI) at NCATS. These equipment will be used to research formulation and manufacturing processes to optimize products’ composition, dosage form, and delivery system to ensure that they are safe, stable, and effective.

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. Furthermore, this system will be used to assist in the formulation development of lead APP candidates and other drug substances into phase I clinical trials.

The tools listed above are essential formulation related laboratory equipment for day-to-day operation in a laboratory.

3. Generic Name of Product: Miscellaneous small laboratory tools/equipment. They include:

Microscope interface

Ultrasonic Cleaning Bath Accessory

Decapper Plier

Flame Resistant Cabinet

13 mm Crimp Vials

20 mm Crimp Vials

Paddle Stirrer

Hotplate 7x7

Ultrasonic Cleaning Bath

Hotplate 10x10

Digital camera for the microscope

Powered crimping/decapping tool

Extruder set

Upright microscope

Overhead stirrer

Peristalitic pumps

LRS for Flammable storage cabinet

Tapped Density

Vortex mixer

4. Purchase Description: For reference purposes, the Miscellaneous small laboratory tools/equipment that meet the need of this requirement (Brand-name or equal) are as follows:

Part Number Description Quantity

03000108 Fisherbrand Advanced Research Grade Upright Microscope:

Head Style: Siedentopf Trinocular head with 30 deg. incline, Magnification Power: 40x, 100x, 400x, 1000x, Design Type: Camera attachment, Model:Infinity Optical System, Objective Types: High Contrast Chromatic-Free objectives

03000043 Fisherbrand C-Mount Digital Camera, Description: Frame Rate: 7.2 at 3584 x 2746, 24.5 at 1792 x 1372, Power Supply Details: DC 5V over PC USB Port, Compatibility: Support Microsoft Windows XP / Vista / 7 /8 (32 and 64 bit), OS X (Mac OS X), Linux

NC2279731 CM2000 0.5XC INTERFACE 1

01183173 IKA EUROSTAR 60 Control Overhead Stirrer, Capacity: 40 L, Display: TFT, Speed: 30 to 2000 rpm, Voltage: 115 V, Wattage: 176 w, Chuck

Size: 0.5 to 10 mm, Dimensions:

230 x 86 x 267 mm (9.1 x 3.4 x 10.5 in.), Frequency: 50/60 Hz, Height: 10.5 in., 267 mm, Includes: RS 232 and a USB interface

01183203 IKA R 1375 Paddle Stirrer, AISI 316L, Diameter: 2.8 in., 70 mm, Diameter Shaft: 0.3 in., 8 mm, Length: 21.7 in., 550 mm, Model: R 1375, Speed: 800 rpm (max.)

03452415 Thermo Scientific Manual Crimper for 13 mm Crimp Vials, For Use With:13 mm Crimp Vials, Stainless Steel/Aluminum, 03452416 Thermo Scientific Manual Crimper for 20 mm Crimp Vials, For Use With: 20 mm Crimp Vials, Stainless Steel/Aluminum

02913057 DWK Life Sciences Battery Powered Crimping/Decapping Tool, Size: 13 mm, Style: Decapping Tool, Electronic, For Use With: Crimping, Height: 184.15 mm, Length: 107.95 mm

02913062 DWK Life Sciences Battery Powered Crimping/Decapping Tool, Size: 20 mm, Style: Decapping Tool, Electronic, For Use With: Crimping, Height: 184.15 mm, Length: 107.95 mm

15050074 Fisherbrand Tall Flammable Storage Cabinet, Capacity: 45 gal, 170.3 L, Depth: 18 in., 45.7 cm, Width: 43 in., 109.2 cm, Cabinet Type: Flammable Storage, Certifications: NFPA, OSHA, FM, Yellow, No. of Doors: 2, No. of Drawers: None, No. of Shelves: 2, Height: 65 in.,165.1 cm

NON-CATALOG LRS INSIDE DEL/FLAME CABINET

Low-Range Sensor (LRS)

NC1400713 PT-TD300 TAPPED DENSITY

Compliance to USP <616>, ASTM B527 and ISO testing standards.

Up to 300 tap/min

NC9273238 Avanti Polar Lipids MINI-EXTRUDER SET

1 Extruder with holder/heating block

2 syringes 1000 uL

100 0.1 um pore size polycarbonate membranes

SP88857200 Fisherbrand Isotemp Stirring Hotplate, Top Plate Material: Ceramic, Plug Type: US-Style, Temperature: Ambient to 540 deg.C, Size: 7.25 x 7.25 in., Shape: Square, Stirring Range: 50 to 1500 rpm, Stirrer, Hot Plate Stirrer, Voltage: 100/120 V, Certifications/Compliance: cCSAus

SP88850200 Fisherbrand Isotemp Stirring Hotplate, Top Plate Material: Ceramic, Plug Type: US-Style, Temperature: Ambient to 540 deg.C, Size: 10 x 10 in., Shape: Square, Stirring Range: 50 to 1500 rpm, Stirrer, Hot Plate Stirrer, Voltage: 100/120 V, Certifications/Compliance: cCSAus

15336130 Branson Ultrasonics CPX Series Ultrasonic Cleaning Bath, Model: CPX1800, Capacity: 1.9L (0.5 gal.), Dimensions Interior: 15 x 14 x 10cm (6 x 5.5 x 4 in.), Voltage: 120V, Hertz: 40kHz, For Use With: Cleaning, Includes: Tank cover, Plastic, Timer:

90 min., Warranty: 2 Years, Weight: 7 lb., 3.2kg

1533721A Branson Ultrasonics Bransonic Ultrasonic Cleaning Bath Accessory, Mesh Baskets, For Model 1510;

Capacity: 0.5 gal.; I.D.: 5.5 x 6 x 4 in., Capacity: 63.99 oz., 63.99 oz., 1.89L, Depth: 3 in., 7.62cm, Length: 5 in., 12.7cm, Width: 4.75 in., 12.06cm

02215418 Fisherbrand Digital Vortex Mixer, Voltage: 120V, Amperage: 1.2 amps, Height Exterior: 5 in., 12.7cm, Length Exterior: 8 in., 20.2cm, Shipping Weight: 10 lb., 5.3kg, Speed: 500 to 3000rpm, Width Exterior: 4.75 in., 12.1 cm, Controller Type: Digital

13820052 Fisherbrand Vial Decapper Plier, Double Action, Diameter Outer: 13 mm and 20 mm, For Use With: 13mm and 20 mm Vial Caps, Vial caps of 13mm and 20 mm size, Stainless Steel, Product Line: Vial Decapper, Plier-style decapper, Certifications/Compliance: ISO 9002, cGMP, 14284120 Watson-Marlow Sci-Q 300 Series Peristaltic Pumps, Certifications/Compliance: CE, IEC335-1, EN60529, Flow Rate: 0.45 to 2000 mL/min., Model: 323E/D, Motor Speed: 15 to 400 rpm, Display Type: LCD, Enclosure Rating: IP31, Voltage: 110/120 and 220/240 V

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

Microscope interface

i. CM2000 0.5XC Interface

Ultrasonic Cleaning Bath Accessory

i. Fit the ultrasonic cleaning bath machine

ii. Stainless steel

iii. Mesh Basket

Decapper Plier

i. Stainless steel

Flame Resistant Cabinet

i. 45 gal, 170.3 L, Depth: 18 in., 45.7 cm, Width: 43 in.

ii. Certifications: NFPA, OSHA, FM

iii. No. of Doors: 2, No. of Drawers: None, No. of Shelves: 2, 13 mm Crimp Vials

i. Stainless steel

20 mm Crimp Vials

i. Stainless steel

Paddle Stirrer

i. Able to fit stirrer

ii. Stainless steel

Hotplate 7x7

i. Dimension 7.25 x 7.25 in.

ii. Temperature: Ambient to 540 deg.C,

iii. Stirring Range: 50 to 1500 rpm, Stirrer,

iv. Hot Plate Stirrer

Ultrasonic Cleaning Bath

i. Capacity: 1.9L (0.5 gal.)

ii. Hertz: 40kHz

iii. Warranty: 2 Years

Hotplate 10x10

i. Dimension 10.25 x 10.25 in.

ii. Temperature: Ambient to 540 deg.C,

iii. Stirring Range: 50 to 1500 rpm, Stirrer,

iv. Hot Plate Stirrer

Digital camera for the microscope

i. Ability to mount on microscope

ii. Frame Rate: 7.2 at 3584 x 2746, 24.5 at 1792 x 1372

iii. Power Supply Details: DC 5V over PC USB Port,

iv. Compatibility: Support Microsoft Windows XP / Vista / 7 /8 (32 and 64 bit), OS X (Mac OS X), Linux

Powered crimping/decapping tool 13mm

i. Ability to crimp 13 mm vials

Powered crimping/decapping tool 20 mm

i. Ability to crimp 20 mm vials

Extruder set

i. Two 1000 uL syringes

ii. 0.1 um pore size polycarbonate membranes

Upright microscope

i. Magnification Power: 40x, 100x, 400x, 1000x

ii. Fit with camera attachment

iii. High Contrast

iv. Chomatic-Free objectives

Overhead stirrer

i. Capacity: 40 L

ii. Speed: 30 to 2000 rpm

Peristalitic pumps

i. Certifications/Compliance: CE, IEC335-1, EN60529,

ii. Flow Rate: 0.45 to 2000 mL/min.

LRS for Flammable storage cabinet

i. Low-Range Sensor (LRS)

Tapped Density

i. Upto 300 tap/min

ii. Compliance to USP <616>, ASTM B527 and ISO testing standards.

Vortex mixer

i. Speed: 500 to 3000rpm

ii. Benchtop

6. Quantity: See quantity listed in the reference table

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 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).

8. Installation: N/A.