WHEN ‘IT’S WHEN’


designed for agile and flexible manufacturing reduces the time and cost of product development.


One of the many reasons for establishing the facility was to ensure that DOD has priority access to a domestic manufactur- ing capability during crises such as chemical or biological events and emerging infectious disease outbreaks. JPEO-CBRND used the manufacturing technologies inherent to the advanced facility to rapidly manufacture multiple vaccines and antibody candidates for clinical trials and deployment to DOD personnel. Devel- opment of the products was in partnership with the National Institutes of Health and the Defense Advanced Research Proj- ects Agency’s Pandemic Prevention Platform teams, which were instrumental in discovering antibodies, screening and choosing lead candidates to transition to the facility for manufacturing to support Phase I and II clinical trials.


Troughout these COVID-19 support efforts, a One Network of Excellence for Regulatory Affairs and Quality Assurance team, a group of regulatory and quality assurance experts, provided exper- tise for rapid development and deployment of the test capabilities, vaccines and therapeutics. Te support of this team was needed to ensure the active management of critical quality parameters


during the development process and that development addressed U.S. Food and Drug Administration requirements, lessening the risk of failure.


To strengthen its support for the national COVID-19 response, DOD also drew on the capabilities of the Global Biosurveillance Portal—a web-based data-visualization and decision-support tool established in 2014 for the U.S. Special Operations Command— as well as DOD and other agencies’ personnel to build situational awareness of the coronavirus. Te addition of both the Johns Hopkins University and World Health Organization COVID- 19 visualization tools provided real-time, up-to-date information to decision-makers, tactical users and action officers. Te Global Biosurveillance Portal continues to add users to provide a whole- of-DOD, whole-of-government approach to the pandemic.


THE WAY AHEAD Developing capabilities that mitigate the impact of current and emerging threats continues to be the primary mission for JPEO- CBRND, even while supporting ongoing COVID-19 efforts. Te urgency of the pandemic response required JPEO-CBRND to simultaneously meet that day-to-day mission while working at a record-breaking pace to execute billions of dollars across dozens


GROWING CULTURE


A lab technician works on a machine used for cell culture growth at DOD’s Advanced Development and Manufacturing Facility in Alachua, Florida. (Photo courtesy of Ology Bioservices Inc.)


GETTING TESTED


Soldiers are tested for COVID-19 on July 28 prior to mobilization for training on Camp Ripley, Minn. (Photo courtesy of JPEO-CBRND)


20


Army AL&T Magazine Winter 2021


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