Development of Novel Drug Particles for Inhalational Therapy

The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to award a Firm Fixed Price, sole source contract on behalf of the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) to Crititech Particle Engineering Solutions, LLC, 1849 E 1450 Rd Lawrence, KS 66044-9452 under authority of 10 United States Code 3204(a)(1) as implemented in Federal Acquisition Regulation 6.302-1 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.

The formulated drug products to be used must be able to fit within the following parameters: • 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.

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. 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. This announcement fulfills the synopsis requirements under FAR 5.203(a).

This Special Notice of Intent is not a request for competitive quotes and no solicitation document exists for this requirement; however, if a vendor challenges the basis for this requirement, please submit a capability statement that includes sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the tasks identified within this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government.

Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement or a sole source procurement is in the best interest of the Government. All questions and responses concerning this notice shall be emailed to Shelley Wallace via email at shelley.a.wallace2.civ@health.mil.

Capability statements are due, in writing, to the email address listed above no later than 10:00 AM Eastern Time, 10 June 2024. Capability statements shall be submitted via email ONLY as Microsoft Word or Adobe PDF attachment. No phone calls will be accepted.