D Attachment 1 Purchase Description.pdf

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

PURCHASE DESCRIPTION

Linkam THMS600 stage (Brand-name or equal), a T96-S temperature controller (Brand-name or equal), and a Nikon microscopy system (Brand-name or equal).

1. Statement of Need and Purpose: This requisition is to purchase a Linkam THMS600 stage, a T96-S temperature controller, and a Nikon microscopy system for the Formulation Lab within the Therapeutic Development Branch (TDB), under the Division of Preclinical Innovation (DPI) at NCATS. This 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.

A thermostage microscope is an important tool for any formulation lab that is involved in the development and testing of materials with thermal properties, such as polymers, pharmaceuticals, and chemicals. The microscope consists of a heating and cooling stage that allows the sample to be observed at different temperatures while undergoing various physical and chemical changes.

Here are some of the key benefits of having a thermostage microscope in a formulation lab:

1. Accurate analysis of thermal properties: A thermostage microscope provides precise control over the temperature of the sample, which is crucial for understanding its thermal behavior. By observing the sample at different temperatures, researchers can analyze the changes in its structure, morphology, and properties, which can help in designing more effective formulations.

2. Real-time observations: The microscope allows researchers to observe the sample in real-time as it undergoes thermal changes, providing insights into its behavior that may not be possible with other techniques. This helps in understanding the mechanisms behind the changes and can aid in developing more efficient formulations.

3. Improved product quality: By using a thermostage microscope, researchers can optimize the formulation process to create products with better quality and performance. They can identify the ideal processing conditions and formulation parameters that result in the desired product properties.

4. Cost-effective solution: The thermostage microscope is a cost-effective solution for analyzing thermal properties compared to other techniques such as differential scanning calorimetry (DSC) and thermal gravimetric analysis (TGA). It requires less sample preparation and can provide faster results.

3. Generic Name of Product: Thermostage Microscopy System

4. Purchase Description: For reference purposes, the Thermostage Microscopy System that meets the need of this requirement is the Linkam’s THMS600 System (Brand-name or equal), T96-S temperature controller (Brand-name or equal), and a Nikon microscopy system (Brand-name or equal), as follows:

Part Number Description Quantity THMS600 LINKAM THMS600 THERMAL STAGE (or equal)

T96-LINK LINKAM T96 CONTROLLER WITH LINK

SOFTWARE (or equal)

PG32C-LINKOP-PKG CAMERA + LINK IMAGE CAPTURE

MODULE UPGRADE (or equal)

9775 STAGE CLAMP FOR NIKON LV100 (or equal)

MDA41005 ECLIPSE LV100N-CH POL (or equal) 1

MBE65275 LV-LH50PC-CH PRECENTERED

LAMPHOUSE (or equal)

MDP44205 P-N CENTERING 5-PLACE NOSEPIECE-

NC (or equal)

79035 POWER CORD (LEAD FREE UL LISTED)

(or equal)

MDB93105 P-TT3 TRINOCULAR TUBE T (or equal) 1 MAK10110 CFI 10X EYEPIECE F.N. 22MM-NC (or equal)

MAK12105 CFI 10X CM CROSSLINE EYEPIECE-NC

(or equal)

MDL11300 STRAIN FREE ACHRO CONDENSER (or equal)

NKSOC20 NKON CONDENSER EXTENSION LENS

20MM (or equal)

QSCREW CUSTOM STAGE SCREW WELDED

SHOULDER (or equal)

MDV40300 NIKON P-CL Quarter and first order wave plate (or equal)

MXA23045 LV-HL50W 12V50W-LL HALOGEN LAMP

(or equal)

MUE13050 TU PLAN FLUOR EPI P 5X (or equal) 1 MUE13100 TU PLAN FLUOR EPI P 10X (or equal) 1 MUE21200 TU PLAN FLUOR EPI ELWD 20X (or equal)

MUE21500 TU PLAN FLUOR EPI ELWD 50X (or equal)

MBB63435 LV-TV-CH, TV TUBE FOR TI3 (or equal) 1 MQD42075 C-0.7X DXM RELAY LENS (or equal) 1

MXA22049 LV-UEPI-N-CH UNIVERSAL EPI

ILLUMINATOR (or equal)

LNP96 LINKAM LNP96 COOLING SYSTEM LIQ

NITROGEN (or equal)

MBE60201 LV-UEPI-N-CH UNIVERSAL EPI

ILLUMINATOR (or equal)

MBN66923 LV-PO POLARIZER FOR LV-UEPI2 (or equal)

TRAINING SET-UP AND TRAINING INCLUDING

TRAVEL

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

Thermostage

1. Temperature control: A thermostage system has the ability to control the temperature of a sample over a wide range of temperatures, from sub-ambient to high temperatures.

2. Thermal stability: The thermostage system must maintain the temperature of the sample with a high degree of stability to ensure accurate and reliable measurements.

3. Heating rate: The heating rate of the system should be controlled and adjustable to provide precise temperature ramping for the sample.

4. Sample stage: The sample stage must be stable and able to accommodate different sample sizes and types, including solids, powders, and liquids.

5. Observation methods: A thermostage system must allow for the observation of the sample during thermal analysis, such as by using optical microscopy or other imaging techniques.

6. Data acquisition: The system must be capable of measuring and recording data such as temperature, heat flow, or mass changes in real-time during thermal analysis.

7. Software and analysis tools: The thermostage system should come with software and analysis tools to help interpret and analyze the thermal data collected during experiments.

8. Delivery

9. Installation

10. 12-month warranty after installation

Microscope

1. Magnification: The microscope should be capable of magnifying the image of the object being viewed, allowing it to be seen in greater detail.

2. Resolution: The microscope should be able to provide a clear, sharp image of the object, with sufficient resolution to distinguish small details.

3. Illumination: The microscope must provide sufficient illumination to view the object being observed, typically through the use of a light source and lenses.

4. Focus: The microscope should have the ability to adjust focus, allowing for precise positioning of the object and the ability to view it in different focal planes.

5. Optical quality: The microscope must be designed with high-quality optics, including lenses and mirrors, to provide a clear and accurate image of the object being viewed.

6. Field of view: The microscope should have a large enough field of view to provide an overall sense of the object being viewed, while also allowing for magnification of specific details.

7. Ergonomics: The microscope should be comfortable and easy to use, with appropriate adjustments for viewing angle and height, as well as convenient controls for focus, magnification, and illumination.

8. Delivery

9. Installation

10. 12-month warranty after installation

6. Quantity: One (1) in each of all products listed in (1-5), (7-13), (15), (17-27); Two (2) in

(6) and (14); and six (6) in (16) in the reference table

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

Therefore, delivery is expected to be performed September 1, 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: 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.

Moreover, where applicable in the Purchase Description, the Contractor shall assure that Installation Qualification (IQ) to stablish by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered as well as Operational Qualification (OQ) to stablish by objective evidence process control limits and action levels which result in product that meets all predetermined requirements are performed in accordance with the manufacturer’s standards and by qualified individuals, as per 21 CFR 820.75(b)(1).