Attachment 1 - Purchase-Description_Copley Inhaler testing kit - Final.pdf

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

PURCHASE DESCRIPTION

Copley Inhaler Testing Kit (Brand-name), distributed by MSP Corporation.

1. Statement of Need and Purpose: This requisition is to purchase an Inhalation testing kit by Copley Scientific Limited for the Formulation Lab within the Therapeutic

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

NCATS. This kit consists of multiple components with capabilities to simulate inhaltion products in adult and pediatric models. These equipment will be used to research formulation and manufacturing processes to optimize inhaltion 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).

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 was 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.

Inhalation therapy has become a cornerstone in the management of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. It has also been utilized to deliver centrally acting medication such as pain analygesic and endocrine compounds. The efficacy and safety of inhalation products heavily depend on the performance of the inhaler device itself. Therefore, investing in comprehensive inhaler testing kits, such as those offered by Copley Scientific Limited, is crucial for ensuring the quality, reliability, and regulatory compliance of these essential medical devices. Copley Scientific Limited is currently the only manufacturer offering a variety of medical devices designed to test and simulate inhalation products for both adult and pediatric models. Their unique impactors and controlled flow testers are industry standards for studying inhalation products, including Metered-Dose Inhalers (MDIs), Dry

Powder Inhalers (DPIs), Nebulizers, and Aqueous Droplet Inhalers (ADIs). The

Inhalation Testing Kit includes the following main components and their function:

• HCP6 pump – Vacuum pump capable of achieving required flow rates for dry powder inhaler testing

• TPK100i – Flow controller with two-way solenoid to accurately regulate flow during testing

• Flow meter – To independently measure flow at the mouthpiece in the NGI setup

• NGI – Next generation cascade impactor to characterize aerodynamic particle size distribution of formulation

• Induction port – USP throat model for NGI testing

• Preseparator – To separate large particles from formulation before entering the impactor

• Gentle rocker – Shaker to mix diluent with deposited active drug on NGI cups

• DUSA tube – Tube with 2 end caps to perform dose uniformity testing

• DUSA shaker – Shaker for mixing diluent with active drug in the DUSA tube

• Alberta Idealized throat – Realistic human throat model for testing (adult and child size)

• Inhalytix – Software for data analysis of aerodynamic particle size distribution

3. Generic Name of Product: Inhalation testing kit (see above for main component details), accssories and services.

4. Purchase Description: For reference purposes, Inhalation testing kit, as follows:

(1) Specify trade name; Copley

(2) Specify product’s brand name; HCP6 Pump, TPK 100i, Flow meter, NGI Impactor, Induction port, Preseparator, Gentle rocker, DUSA tube, DUSA shaker, Alberta Idealized throat for adult, Alberta Idealized throat for pediatric, and Inhalytix software.

(3) see below

5. Salient characteristics The salient physical, functional, or performance characteristics are as follows:

Catelog Number Description Number needed

0001-01-7921 HCP6 High Capacity Pump 120V/60 Hz:

designed for use in the testing of MDIs, DPIs, nebulisers and nasal products in accordance with the specifications laid down in the Ph.

Eur. and USP.

0001-01-9197 Critical Flow Controller TPK 100i Rev Uni

Voltage: designed to measure the pressure drop across the device and control the flow conditions during testing.

0001-01-8764 Flow Meter DFM 2000, 200L/min Air O2 N2

110V: Capable of measuring volumetric flow and calibrated for exit flow as opposed to inlet flow.

0170-02-5073 ADAPT 4043/DFM2000 to IP/DUSA (MSP):

Adaptor for Flow Meter DFM 2000

0170-02-2000 "NGI+" Next Gen Impactor: high performance, precision cascade impactor suitable for the APSD characterisation of all types of OINDPs. Ideal for testing at all flow rates specified in the relevant pharmacopoeias.

0170-01-0149 Induction Port NGI USP Type: Designed for the measurement Adapter can be placed between the inhaler and the NGI induction port to measure the pressure drop (P1) over the inhaler under test in the absence of a

DUSA for DPIs.

0170-98-5008 Cup Set/8 (2Lrg/6Sm) for NGI: Sample collection cups

0170-78-0085 NGI Cup Tray Standard: For the convenient storage of a full set of NGI Cups, protecting the critical surfaces from inadvertent damage and dust collection when not in use.

0170-01-0094 Preseparator NGI Nickel-Coated Insert: to catch any powder boluses and large non-inhalable particles. Offeringhigh capacity, high efficiency, two-stage separation, the NGI

Preseparatorprovides a sharp and reproducible cut-point of between 10 and

15microns depending on flow rate.

6011579 Adapt OInhal RS01 MOD7 DPI to IP/DUSA:

Adaptor for IP/DUSA tube

0001-01-0550 GENTLE ROCKER GR200I: Agitates the NGI

Collection Cup Tray in a controlled, repeatable manner to ensure complete dissolution of the active drug prior to analysis.

0001-01-0553 DOC IQ/OQ GENTLE ROCKER GR200i:

Performance test and qualification

0001-01-9841 Kit DUSA-DPI Tecapro PTC Silic: Dose

Uniformity Sampling Apparatus measurestotal amount of drug emitted from the drug device that is available to the user, when the device is actuated correctly

0001-01-9836 Tub DUSA-DPI w/o P1 w/oCapTec: DUSA accessories

0001-01-9831 Cap Rins DUSA-DPI Tec Silic: DUSA accessories

0001-01-8120 Inhal Test WorkSta-Baseplate and Upright:

Baseplate to support Inhaler Testing

Workstation.

0001-01-8132 Holder Inhal Test Worksta DPI DUSA:

holder for Inhlation Testing Workstation.

0001-01-8135 Holder Inhal Test Worksta DFM2000:

holder for Dose Flow Meter.

0001-01-8630 DUSA Shaker w/o Coll Tubes DTS100i

Univ: Holding up to 21 MDI DUSA collection tubes, the DUSA shaker automates the internal rinsing of the tubes to ensurefull, fast and repeatable drug dissolution and drug recovery from internal surfaces.

0001-01-8621 Doc IQ/OQ DUSA Shaker: Performance and qualification for the shaker

0001-01-9861 Doc IQ/OQ Inhaler Test Systems:

Performance and qualification for the Inhaler test system

9999-99-9955 Trav IQ/OQ Dom 1st Day Inha Prod: Travel for performance, qualification testing, and training for day 1

9999-99-9956 Trav IQ/OQ Dom 2nd/Sub Day Inha Prod:

Travel for performance, qualification testing, and training for day 2

0001-01-8511 Throat Albert Ideal ADULT Alum: Adult throat and lung simulator

0001-01-8514 Adapt FlowMeter to AIT Adult: Adaptor for

Albert Idealised Throat

0001-01-8518 Inlet Cap/Outlet Adapt AIT Adu: Adaptor for inlet and outlet for the adult Albert Idealised

Throat

0001-01-8530 Throat Albert Ideal CHILD Alum: pediatric throat and lun simulator

0001-01-8531 Adapt FlowMeter to AIT Child Version:

Adaptor for pediatric Albert Idealised Throat

0001-01-8533 Inlet Cap/Outlet Adapt AIT Chi: Adaptor for inlet and outlet for the pediatric Albert

Idealised Throat

0001-01-9953 Glass Fiber Filters, 47 mm, Pkg 100 1

0001-01-9668 Sftwr Inhalytix 3-User License – PC:

Inhalytix Software licence for three user

6. Quantity: see products listed in the reference table

7. Delivery Date: 8-14 Weeks ARO

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).