Biomaterial manufacturing suite in support of NIH/niaid and the global infectious disease research community project director: rebecca bradford, MBA, MS, PMP® project summary the project is to…

Biomaterial manufacturing suite in support of NIH/niaid and the global infectious disease research community project director: rebecca bradford, MBA, MS, PMP® project summary the project is to construct and commission a biomaterial manufacturing suite (BMS) as an expansion within the high containment facility (HCF) currently under design at the american type culture collection (atcc). Atcc is a non-profit entity in manassas, virginia, serving the federal government for over 50 years through our federal solutions (AFS) division. The proposed aim of the BMS is to provide modern and reproducible large-scale biomaterial manufacturing capabilities for priority pathogens. Residing within the soon-to-be-built HCF, the BMS will offer the national institute of health and the national institute of allergy and infectious diseases (NIH/niaid) high-throughput and rapid development pipelines for biomaterials of public health concern, including those of epidemic or pandemic potential. The BMS will directly support federal agencies and the infectious disease research communities by optimizing pathogenic organisms' growth, production, and characterization for downstream use. By funding the BMS within the planned facility, AFS can enhance our support to NIH/niaid through our ability to offer large-scale stocks of well-characterized challenge materials at no cost to the research community through AFS managed programs, including BEI resources. In turn, this will accelerate infectious disease research for vaccine and therapeutic development in outbreak situations and serve as biological standards for developing detection assays. AFS' current modular 7,500 FT2 HCF was built in 2007 as a temporary solution to facilitate the expanding needs of AFS' health and human services (HHS) programs. The facility is now over- extended with respect to lifespan, capacity, and capabilities. AFS dutifully maintains the upkeep of the current HCF to support the extensive NIH/niaid requests for biological products to advance our medical countermeasures and arsenal against variants for the recent onslaught of the covid- 19 pandemic. As a non-profit organization, atcc has committed several million dollars to design and construct a new HCF to enhance and modernize our support to NIH. The explicit goal of this funding is to include the design, construction, and commissioning of the BMS within the facility footprint to provide critical biological manufacturing capabilities in the biomedical space to accelerate translational research for vaccine and therapeutic development.