DEVELOPMENT OF A FORMULATION-AGNOSTIC AUTOINJECTOR PLATFORM

The Department of War, through the Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense and the Joint Project Manager for CBRN Medical, is seeking industry input on a formulation-agnostic autoinjector platform designed to deliver a range of medical countermeasures under demanding military conditions. The device must handle single-chamber liquid, dual-chamber liquid-liquid, and dual-chamber solid-liquid reconstitution formulations with a delivery volume range of 0.4 mL to 5.0 mL, accommodating varying fluid viscosities without hardware modifications. Critical performance requirements include a 99.999% FDA-validated reliability rate over the product lifecycle, ruggedization to MIL-STD-810H standards to enable intramuscular delivery through MOPP and ACU gear, and a shelf-life of at least two years with a target of five years at controlled room temperature. Initial target compounds include Atropine, Pralidoxime Chloride, Midazolam, and Naloxone, with the platform designed to support future expansion to additional agents. The autoinjector must enable hands-free reconstitution without user intervention, provide tactile differentiation for use in low-visibility environments, and support self-administration under stress, with labeling and design features ensuring usability while wearing protective gear. Respondents are required to demonstrate regulatory experience with FDA pathways for combination products, cGMP manufacturing capabilities, and a viable commercialization strategy that supports dual-use applications beyond military procurement. Proposals must be submitted via email no later than 1600 EST on August 7, 2026, limited to ten pages total—two pages for company background and data rights, and eight pages for technology and manufacturing capability. All proprietary information must be marked as “Company Proprietary,” and submissions must not include government security classifications. The government will evaluate inputs to inform future procurement decisions, with no obligation to award a contract at this stage. Responses must include rough order of magnitude cost estimates, though no pricing or CLIN data is requested. The anticipated place of performance is Gunpowder, Maryland, and submissions must be addressed to three designated government email contacts. While no formal contract clauses, payment details, or award criteria are established, the platform’s design must align with FDA standards, MIL-STD-810H environmental durability, and long-term sustainability through scalable manufacturing and intellectual property management.