Development of a formulation-agnostic autoinjector platform

Closed Pre-Solicitation Posted

Solicitation number
W911SR-26-PLATFORM
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Gunpowder, Maryland 21010, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of the Army, Joint Project Manager for CBRN Medical, is soliciting information on formulation-agnostic autoinjector platform designs with responses due August 7, 2026. This is a Request for Information for market research purposes only and does not constitute a commitment to issue a solicitation.

The autoinjector must deliver single-chamber liquid, dual-chamber liquid-liquid, or dual-chamber solid-liquid (reconstitution) formulations with FDA-validated reliability of 99.999% over product lifecycle. The platform must accommodate delivery volumes from 0.4 mL to 2.0 mL (threshold) up to 5.0 mL (objective) across varying fluid viscosities without primary assembly-line modifications. It must achieve MIL-STD-810H compliance for ruggedization, enabling intramuscular delivery through Mission Oriented Protective Posture gear and Army Combat Uniforms. Target compounds include Atropine, Pralidoxime Chloride, Midazolam, and Naloxone. The platform must support a two-year minimum shelf-life (five-year objective) and incorporate tactile differentiation for field safety.

Responses must be submitted via email by 1600 EST August 7, 2026. White papers must not exceed ten pages and address company overview with FDA-compliant medical device experience, technical solution including prototype design and formulation-agnostic delivery mechanisms, FDA regulatory pathway strategy, cGMP manufacturing capabilities, and commercial business case with production scalability and dual-use commercialization pathways. Respondents must provide Rough Order of Magnitude cost estimates through FDA approval and clearly mark proprietary information. The Government will contact qualifying respondents within four weeks of the deadline for follow-up discussions.

Notice text

The Department of War (DoW), Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE CBRND), Joint Project Manager for CBRN Medical (JPM CBRN Medical) is seeking information, design concepts, and capabilities for a Formulation-Agnostic Autoinjector Platform.

The goal of this initiative is to identify or develop a modular, ruggedized, and highly reliable autoinjector device capable of delivering single-chamber liquid, dual-chamber liquid-liquid, or dual-chamber solid-liquid (reconstitution) formulations.

Key Technical Parameters & Scope:

  • Reliability: Must design toward or meet an FDA-validated reliability threshold of 99.999% over the product lifecycle.

  • Flexibility: Capable of delivering volumes ranging from 0.4 mL to 2.0 mL (Threshold) up to 5.0 mL (Objective) across varying fluid viscosities without design modifications to the primary assembly line.

  • Ruggedization: Capable of meeting or being ruggedized to MIL-STD-810H standards, ensuring intramuscular (IM) delivery through Mission Oriented Protective Posture (MOPP) gear and Army Combat Uniforms (ACU).

  • Target Compounds: Initial candidates include Atropine, Pralidoxime Chloride (2-PAM), Midazolam, and Naloxone.

  • Commercialization: The Government seeks platform designs with clear dual-use pathways for sustainable commercial market viability beyond military procurement.

This RFI is for market research and planning purposes only. It does not constitute a solicitation, nor does it restrict the Government's ultimate acquisition strategy.

Files

File Type Posted
DS-PubRel-FY26-0088 - Autoinjector Platform RFI_JUL26_Final_v4 .docx DOCX document
Autoinjector Platform RFI .png PNG image

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