D1 Purchase Description.pdf

FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

Agilent UV Dissolution System w/ 708-DS dissolution apparatus, 850-DS sampling station, and Cary60 fiber optic UV dissolution system (Brand-name or equal). This is a COVID-19 requirement.

1. Statement of Need and Purpose: The Formulation Lab within the Therapeutic

Development Branch (TDB), under the Division of Preclinical Innovation (DPI), within the National Center for Advancing Translational Sciences (NCATS) seeks to purchase a Dissolution System composed of dissolution apparatus, sampling station, and fiber optic UV dissolution system 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 dissolution system is a critical piece of equipment in a formulation lab for several reasons:

1. Quality control: Dissolution testing is a critical quality control parameter for many drug products. The dissolution apparatus is used to simulate the conditions of the human gastrointestinal tract and measure the rate at which the drug substance dissolves. This information is used to ensure that the drug product meets the required dissolution specifications.

2. Formulation development: The dissolution apparatus is also used in formulation development to optimize the formulation of a drug product. By testing the dissolution profile of different formulations under various conditions, researchers can determine the best formulation that will provide the desired pharmacokinetic profile.

3. Regulatory compliance: Dissolution testing is a requirement for drug product approval by regulatory agencies, such as the US FDA. The dissolution apparatus is used to perform these tests and provide the necessary data to support regulatory submissions.

4. Batch-to-batch consistency: The dissolution apparatus is used to ensure that the drug product remains consistent from batch to batch. By testing the dissolution profile of each batch, manufacturers can identify any changes in formulation or manufacturing process that may affect the drug product's dissolution rate.

Thus, NCATS DPI TDB requires a Dissolution System composed of dissolution apparatus, sampling station, and fiber optic UV dissolution system capable of automating the lab’s full dissolution test, from sample introduction to sampling and analysis as well as seamlessly analyze the dissolution samples in real time in order to further advance the research formulation and manufacturing processes to optimize products’ composition, dosage form, and delivery system to ensure that they are safe, stable, and effective.

3. Generic Name of Product: Dissolution System composed of dissolution apparatus, sampling station, and fiber optic UV dissolution system.

4. Purchase Description: For reference purposes, the Dissolution System composed of dissolution apparatus, sampling station, and fiber optic UV dissolution system that meets the need of this requirement is the Agilent Technologies, Inc UV Dissolution System w/ 708-DS dissolution apparatus, 850-DS sampling station, and Cary60 fiber optic UV dissolution system (Brand-name or equal), as follows:

Part Number Description QTY

G7926A 708-DS and Cary 60 UV Disso – Multicell Includes 708-DS Dissolution Apparatus, Cary 60 UV-Vis Spectrophotometer 18-cell holder and applicable accessories for each instrument.

a) 708-DS Dissolution Apparatus

b) Cary 60 UV-Vis Spectrophotometer

c) 18-cell holder

d) 850-DS Dissolution Sampling Station

e) 96-position Sample Tray

f) Cary 60 flow Cell, 10 mm, set of 8

G9261AA UV Dissolution SW Bundle-Multicell 1 G7931A 850-DS Filtration Module. Includes integrated filtration module for use with exclusive filter plates for 0.45 micron filtration

SYS-DI-708-E Dissolution 708DS Apparatus Enhanced Features, CrossLab Qualification Installation Qualification (IQ)

SYS-UV-60 UV-VIS Cary 60 System, CrossLab Installation Qualification (IQ) and Operational Qualification (OQ)

SYS-SW-CS-E Anallytical Sofeware with Security, CrossLab Installation Qualification (IQ) and Operational Qualification (OQ)

DELIVERY FOB DESTINATION 1

INSTALLATION 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:

• Dissolution Apparatus o Capable of performing dissolution testing on a wide range of dosage forms, including tablets, capsules, and suspensions.

o Automated sampling and data collection.

o Easy customization, allowing researchers to modify the system to meet their specific testing needs.

o Compliant with regulatory requirements, including the US Pharmacopeia (USP) testing standards.

o Capable of performing manual or automated dissolution testing.

o Capable of being configured for use with baskets (Apparatus 1), paddles (Apparatus

2), paddle over disk assemblies (Apparatus 5), and rotating cylinders (Apparatus 6) o Capable of accommodating vessel sizes from 100 mL to 2 L.

o Seamless compatible with the Sampling Station and Dissolution System o Installation qualification (IQ)

• Sampling Station o Automated dissolution sampling from dissolution apparatus 1, 2, 3, 5, 6, and 7.

o Capable of filtering, withdrawing, and archiving samples for future HPLC and UV analysis.

o Variable pump speeds with shorter timepoint intervals and handling of different media types, including surfactants.

o Multiple sample tray options, including ability to sample directly into HPLC sample trays that can be placed directly into the HPLC sampling station, eliminating manual vial transfer.

o Seamless compatible with the Dissolution Apparatus and Dissolution System o Installation Qualification (IQ) and Operational Qualification (OQ)

• Fiber Optic UV Dissolution System o Analyzes samples in situ through fiber optic probes mounted on a moveable manifold that ensures precise sampling position and minimizes hydrodynamic disturbances.

o Xenon flash lamp technology to provide a linear absorbance range of greater than

3.5 Abs.

o Transmission and reproducibility capabilities.

o Rapid time point requirements with the ability to take readings as often as every 45 seconds.

o Samples are read directly in the dissolution vessel.

o Analyze the dissolution samples in real time.

o Corrects for samples with excipient and background interferences.

o Seamless compatible with the Sampling Station and Dissolution Apparatus o Installation Qualification (IQ) and Operational Qualification (OQ)

• Dissolution Software.

o Software shall support the Dissolution Apparatus and easily pairs with the Dissolution Sampling Station for accurate preparation of samples and optional archiving.

o Software shall control apparatus features, such as dosage delivery, automated sampling, and vessel temperature monitoring.

o Software shall provide data processing and reports available for samples taken offline using the UV dissolution manual program.

o Support media change methods, capsule blank correction, and check standards.

o Offline standards can be used in a variety of ways to prevent standard preparation for each test.

o Test reports can be customized to include relevant data in NCATS desired format.

o 21 CFR Part 11 compliance package is included for electronic records and secure data storage.

• Delivery FOB Destination.

• Installation

• 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 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).