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.
PHASE I
The objective of Phase I is to conduct a feasibility study using an existing BOND platform. This activity may include producing high purity proteins with consistency, advancing glycosylation approaches, developing lysate, exploring AI/ML process analytic techniques, or proposing novel anti-infectious biologics. Successful completion of Phase I should provide evidence that a higher Technology Readiness Level maybe achieved with a specified platform.
PHASE II
This solicitation seeks proposals for a robust, portable biologics-on-demand system capable of producing GMP-like protein. Offerors must demonstrate a ruggedized BOND platform with reproducible, scalable, and high-quality throughput. Proposed solutions may involve (but are not limited to) developing ML/AI processing, sensor validation, lysate optimization, and resin modification. Final demonstration should include the production of weekly batches with verification of consistent product quality.
PHASE III DUAL USE APPLICATIONS
PHASE III: The end goal of Phase III will be a BOND device capable of producing GMP-like proteins and ready for FDA evaluation. Such activities may include manufacturing replicate platforms and conducting multiple batch runs for product evaluation. A successful outcome of PHASE III will be to demonstrate that the BOND device is capable of meeting or surpassing existing production methods of a currently approved FDA protein.
REFERENCES
Srai, J. S., Kumar, et al. (2016). Distributed manufacturing: scope, challenges and opportunities. International Journal of Production Research, 54(23), 6917-6935.
Borhani, S. G., Rao, G., et al. (2023). An approach to rapid distributed manufacturing of broad spectrum anti-viral griffithsin using cell-free systems to mitigate pandemics. New Biotechnology, 76, 13-22.
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