Background
The Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response (ASPR) has released a Draft Statement of Objectives (SOO) for feedback to help refine requirements for the upcoming “Smart Manufacturing” solicitation aiming to support the development of advanced monoclonal antibody (mAb) manufacturing and development techniques. The solicitation’s overarching goal will be to implement FDA “Advanced Manufacturing” concepts to improve drug quality, address shortages, and reduce time-to-market building on the proven role of mAbs in recent responses to anthrax, Ebola, Respiratory Syncytial Virus (RSV), and SARS-CoV-2.
Solicitation Overview
BARDA will seek innovations that apply “smart manufacturing” (automation, digitization, artificial intelligence) to streamline mAb production, increase process-control data collection, and enable adaptive, algorithm-driven decisions for production or release, ideally in approaches that can extend across medical countermeasures (MCMs). Qualifying projects should measurably improve quality, cycle time, flexibility, and cost in mAb manufacturing aligned to FDA Advanced Manufacturing objectives.
Specific Goals & Eligibility
Offerors must be actively advancing a post-Phase II drug candidate and demonstrate secured funding to support progression through licensure. Technologies should be between Technology Readiness Levels (TRL) 4–6, with a program goal to demonstrate at TRL 6. Within three years of award, performers should deliver a GMP-qualifiable proof of approach on a scalable system, produce operational data quantifying improvements and return on investment (ROI), and provide documentation supporting the proposed TRL.
Competitive projects will show measurable gains in one or more areas: efficiency/productivity (e.g., cycle time, throughput), cost-effectiveness (e.g., cost per gram, maintenance), scalability/flexibility (e.g., changeover time, capacity utilization), data utilization/insights (e.g., predictive analytics, decision speed/accuracy), and regulatory compliance (e.g., deviation rates, CAPA timelines).
Why This Matters For Human Health
Modernizing mAb manufacturing with automation, advanced analytics, and adaptive control will allow BARDA to better develop and provide high-quality therapeutics to patients, reduce shortages, and strengthen U.S. readiness against current and emerging biological threats.
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