In the rapidly evolving landscape of public health, the ability to swiftly and efficiently produce medical countermeasures (MCMs) is paramount. The Biomedical Advanced Research and Development Authority (BARDA) is spearheading this effort with its innovative On-Demand Manufacturing program. This initiative is designed to revolutionize the production and distribution of MCMs by developing portable, continuous, and end-to-end manufacturing systems.
Understanding the On-Demand Manufacturing Program
The On-Demand Manufacturing program is a bold initiative aimed at accelerating the development of portable, continuous manufacturing systems capable of producing MCMs on demand. This program is not about creating a single product but rather enhancing the entire manufacturing process to support emergency preparedness and response missions. This means ensuring rapid and flexible production of MCMs during public health emergencies.
Key aspects of the program include developing portable, self-contained systems that can be deployed quickly to areas of need. The focus is on optimizing single-component manufacturing technologies that can be integrated into a complete end-to-end system. This integration is vital for establishing a network of deployable manufacturing systems that can be used during pandemics and localized outbreaks.
What Makes an Ideal On-Demand Manufacturing Platform?
The ideal platform under this program will exhibit several critical characteristics. Continuous manufacturing is at the heart of the design, with automated processes requiring minimal operator involvement. The systems must ensure consistent production quality and rapid synthesis, purification, and release of products. Scalability is another crucial factor, allowing processes to meet varying demand levels.
Quality and consistency are maintained through in-line analytical methods, while the platform’s small physical footprint ensures portability and ease of deployment in various environments. Furthermore, the ability to produce dosage-ready forms and transfer technologies for scale-out are essential for meeting the program’s objectives.
Eligibility and Proposal Criteria
To be considered for this program, your proposal must demonstrate how a single-component technology will be integrated into a larger on-demand system. Importantly, you need to show the capability to produce an MCM, focusing particularly on SARS-CoV-2 or other BARDA mission threats, under Good Manufacturing Practice (GMP) conditions.
Competitive proposals will stand out by clearly articulating how the proposed technology addresses the key components of the Target Platform Profile (TPP). This includes detailed quality measures across the process continuum and a comprehensive regulatory and commercial development plan. A multi-partner effort that leverages existing capabilities and strengths will be highly regarded.
It’s crucial to note that proposals focused on the development of novel delivery devices, preclinical or clinical evaluation of candidates, or technologies for diseases outside BARDA’s mission will not be considered.
Project Funding and Phases
The On-Demand Manufacturing program is structured into three phases, starting with initial funding covering only Phase 1. This phase includes engineering and prototyping or integration and proof-of-concept, laying the groundwork for developing early technologies or a complete end-to-end manufacturing system.
Phase 2 will focus on optimizing the system and demonstrating a small-scale production run, while future phases, subject to funding, will involve full-scale production and the integration of new technologies.
For organizations interested in participating, here are the key dates to keep in mind:
- RPP Release Date: June 1, 2024
- Proposal Due Date: September 30, 2024
- Expected Award Date: December 15, 2024
BARDA’s On-Demand Manufacturing program represents a groundbreaking shift in how MCMs are produced and deployed. At [Your Consulting Firm], we are committed to helping your organization navigate this transformative initiative. Our expertise can guide you through the proposal process, ensuring your submissions are aligned with BARDA’s objectives and positioned for success.
The Next Steps
Engaging with the On-Demand Manufacturing program offers a unique opportunity to be at the forefront of public health preparedness, contributing to the development of lifesaving MCMs that are available where and when they are needed most. Partner with us to leverage this opportunity and make a significant impact on global health security.
If your company has considered applying for BARDA funding, your federal funding journey starts here. EverGlade Consulting is a national consulting that helps organizations win and manage federal awards. We offer services ranging from Pursuit, Proposal and Post-Award support to comply with federal regulations at agencies including BARDA, ASPR, NIH, DTRA, JPEO, DOD, DIU, DOE, and DARPA.