OPEN TOPIC - Expeditionary Biologics-on-Demand (BOND)

Objective: Develop a portable, high-performance BOND system for point-of-care protein production by maximizing protein purity, potency, and quality. This can be achieved through automated process control, incorporating soft sensors, machine learning, and real-time data analytics to predictively and autonomously adjust production parameters for optimal yield. Description: On-demand distributed protein production offers significant advantages, including the creation of diverse therapies, vaccines, diagnostics, and detection biologics. It also streamlines delivery, eliminates cold-chain requirements, reduces R&D costs, and enables rapid scaling for better supply-demand matching1. Deployable, modular BOND systems can enhance supply chain resilience and broaden medical countermeasure capabilities by enabling on-site protein production in forward-deployed locations. Similar to the impact of 3D printing on manufacturing, these compact systems offer a transformative approach to producing medical treatments where they are needed. Such technologies may enable multi-nodal point-of-need manufacturing capability. Single-platform systems have proven capable of producing a wide range of proteins due to advancements in lysate production, scaling, and automation2. However, ensuring consistent batch quality and reproducibility that meet regulatory standards remains the primary hurdle for widespread adoption of portable protein production. Integrated analytics coupled with machine learning may offer a solution by providing unprecedented levels of batch purity and consistency. Keywords: Protein, Manufacturing, Therapeutics, Diagnostics, Protection