A02-JA_updated information_ Inhaled Drug Delivery_FE_06.20.2024_updated_09.10.2024_Redacted.pdf

CUI

Control Number: JA-24-04-1527

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

Justification and Approval for Other than Full and Open Competition � FAR Part 6

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA), 808 Shreider Street, Fort Detrick, MD 21702-5014

2. Description of Action: The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) requires a five (5) year Indefinite Delivery / Indefinite Quantity (IDIQ) contract.

The resultant task orders will be Firm Fixed Price (FFP). The task orders will be funded with FY24 Defense Threat Reduction Agency (DTRA) funds. The proposed source is Crititech Particle Engineering Solutions, LLC (CAGE Code 7UD60), 1849 E 1450 Rd Lawrence, KS 66044-9452.

3. Description of Supplies/Services: The ability to deliver long-lasting antimicrobials to the lungs would provide a novel, highly advantageous medical countermeasure that would be easily deployable with the Warfighter. However, a critical component of the development of such countermeasure is engineering a product suitable for long-lasting pulmonary deposition due to limitations of older technologies that rely on large amounts of excipients and have unoptimized particle sizes. For pulmonary delivery, only particles of a certain range (~0.5-5 µm) are expected to be retained in the lung. A high surface area on particles of this size (~15-100 m2/g) will ensure a longer-acting affect within the lung tissue and avoid rapid dissolution into systemic circulation. Layering these two requirements together leads to large surface area microparticles (LSAM) that have the benefits of both parameters simultaneously. In addition, the requirement for no-to-low excipient use ensures that a smaller total delivered dose is used and will allow for micronization of downstream delivery platforms. There currently exist LSAM used in oncology in clinical trials, which would boost confidence in this approach in terms of a proven track record to produce cGMP material. However, this current requirement focuses on the development of antimicrobials of specific interest to the biodefense community and will require an iterative testing and evaluation workflow that will require multiple types of solid/crystalline forms of various drugs to be processed and then empirically testing in animal models. In this requirement, the Contractor will be optimizing processes active drug products (API) purchased through commercial vendors and providing various lots of material for testing in animal exposure chambers suitable for dry-powder drug delivery.

The primary objective of this requirement is to develop novel, super-critical precipitated drug products suitable for inhaled drug delivery for the treatment of pulmonary infections. This is a new requirement based on a Defense Threat Reduction Agency (DTRA) funded project to USAMRIID Bacteriology specifically for the testing and development of inhaled countermeasures.

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Emily K. O� Hara (301)619-9599

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

The estimated value of this effort is , inclusive of all options.

4. Authority Cited: 10 United States Code 3204(a)(1) as implemented in Federal Acquisition Regulation 6.302-1 Only One responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: Of the three (3) entities identified as potential sources, only one

(1) was deemed capable of fulfilling the needs of the Government. The potential sources researched were as follows: 1. Crititech Particle Engineering Solutions, LLC 2. Lonza Small Molecule and 3. The Jet Pulverizer Company.

Market research revealed CritiTech Particle Engineering Solutions, LLC is the sole provider capable of developing novel, super-critical precipitated drug products suitable for inhaled drug delivery for the treatment of pulmonary infections. This vendor has a proprietary technology (Purcision) that relies on supercritical precipitated API to produce particles in the correct size for inhalation (0.5 � 5.0 µm) with very high surface area and no drug excipients, which allows for high drug loads compared to other methods. This vendor is the sole source of LSAM used for oncology programs and has a demonstrated track record as a formulations contract research organization (CRO).

The other vendors that were researched such as Lonza Small Molecule CDMO and The Jet Pulverizer Company offer spray-drying, jet milling, and micronization services that are common approaches to dry drug inhaled delivery; however, these techniques do not produce particles of the desired parameters listed below.

Particle Size: ~0.5-5 µm Surface Area: 15-100 m2/g while retaining required particle size Drug excipient use: <5% w/w of total particle The overall product parameters should be generally accepted to be compatible with an inhaled drug product with deep lung deposition and long retention times.

None of these services can deliver particles that match all requirements simultaneously. Jet-milling can only produce particles in the desired range with surface areas much lower than acceptable (<10 m2/g) and require co-milling with an excipient for good aerosolization. Spray-drying often requires large excipient burdens and has a lower than acceptable particle size/surface area ratio than set in the parameters. Additionally, there are other vendors who offer micronization and jet milling similar to Lonza Small Molecule CDMO and The Jet Pulverizer Company, but the limitations are common across all as the limitation is based on the technique itself.

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted on 14 May 2024 to sam.gov with a closing date of 21 May 2024. As a result, one (1) response was received, from Emphascience (CAGE Code 7XRP9), 115 Sully�s Trail, Suite 6, Pittsford, NY 14534, USA.

After TPOC reviewed the capability statement, it was determined that Emphascience�s

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

techniques do not make the requirement and do not refer to using a dry powder delivery. A Notice of Intent to Sole Source was posted on 24 May 2024 with a closing date of 10 June 2024.

Two other inquiries were made, one from Pilgrimlabs via email, no capability statement was presented, the other inquire made from IITRI, and no capability statement was presented.

a. Effective competition. The Government intends to make an award to Crititech Particle Engineering Solutions, LLC (CAGE Code 7UD60), 1849 E 1450 Rd Lawrence, KS 66044-9452 on a sole source basis; therefore, no competition is expected for this action.

b. Subcontracting competition. Because the selection of research and development Contractors is substantially based on the best scientific and technological sources, it is important that the Contractor not subcontract technical or scientific work without the Contracting Officer�s advance knowledge.

7. Actions to Increase Competition: The Government will continue to survey the market by posting Requests for Information (RFIs) and Sources Sought Notices (SSN) on www.sam.gov as required.

8. Market Research: The market research team performed multiple internet searches seeking to determine what companies have the capabilities required to fill the needs of this requirement. Of the three (3) entities identified as potential sources, only one (1) was deemed capable of fulfilling the needs of the Government. The potential sources researched were as follows: 1. Crititech Particle Engineering Solutions, LLC 2. Lonza Small Molecule and 3. The Jet Pulverizer Company.

Research indicated CritiTech Particle Engineering Solutions, LLC is the sole provider capable of developing novel, super-critical precipitated drug products suitable for inhaled drug delivery for the treatment of pulmonary infections. CritiTech Particle Engineering Solutions, LLC holds a proprietary technology (Purcision) that relies on supercritical precipitated API to produce particles in the correct size for inhalation (0.5 � 5.0 µm) with very high surface area and no drug excipients, which allows for high drug loads compared to other methods. This vendor is the sole source of LSAM used for oncology programs and has a demonstrated track record as a formulations CRO.

The other vendors that were researched such as Lonza Small Molecule CDMO and The Jet Pulverizer Company offer spray-drying, jet milling, and micronization services that are common approaches to dry drug inhaled delivery; however, these techniques do not produce particles of the desired parameters listed below.

Particle Size: ~0.5-5 µm Surface Area: 15-100 m2/g while retaining required particle size Drug excipient use: <5% w/w of total particle The overall product parameters should be generally accepted to be compatible with an inhaled drug product with deep lung deposition and long retention times.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

None of these services can deliver particles that match all requirements simultaneously. Jet-milling can only produce particles in the desired range with surface areas much lower than acceptable (<10 m2/g) and require co-milling with an excipient for good aerosolization. Spray-drying often requires large excipient burdens and has a lower than acceptable particle size/surface area ratio than set in the parameters. Additionally, there are other vendors who offer micronization and jet milling similar to Lonza Small Molecule CDMO and The Jet Pulverizer Company, but the limitations are common across all as the limitation is based on the technique itself.

9. Interested Sources: To date, no other sources have written to express an interest.

The notices required by FAR 5.201 shall be published, and any bids or proposals received shall be considered.

10. Other Facts: Not applicable. This is a new requirement.

a. Procurement history. In the first year of the associated funded project, small quantities of test material were provided by the proposed Contractor (CritiTech) as either a sample or purchased via GFEBS GPC order. The GPC orders were for small amounts of preliminary material and were roughly for 1-15g of processed material. This generally included analytical support and preliminary testing at the vendor�s site. Given the scope and breadth of the requirement is expanding into CY24+, this GPC arrangement is no longer deemed appropriate.