Good Laboratory Practice (GLP)

USAMRIID is the Department of Defense's lead laboratory for medical biological defense research. With our highly trained workforce and specialized containment facilities, we are uniquely positioned to move candidate medical countermeasures (MCM)–vaccines, therapeutics, and diagnostic assays–out of the technology base and into advanced development. About 150 GLP studies have been conducted at USAMRIID across all levels of biocontainment, including Biosafety Level (BSL)-4 laboratories.

Good Laboratory Practice

• Capability to perform GLP studies in BSL-2, BSL-3, and BSL-4 laboratories
• FDA-inspected GLP facilities and processes
• Over 1,000 GLP-enabling Standard Operating Procedures (SOPs), fully approved and version controlled
• Biological Select Agents and Toxins characterized, inventoried, and tracked for GLP challenge studies
• Study directors mentored and trained to successfully manage large, complex GLP studies in biocontainment

Quality Assurance

• Expert, industry-trained and credentialed GLP Quality Assurance (QA) Unit performs regular audits and inspections of BSL-2, BSL-3, and BSL-4 studies and facilities
• GLP-facilitating core services provide statistics, equipment and software validation, and clinical pathology
• Fully competent GLP archives and GLP test/control article management
• Validated assays with sufficient reagents ready to support GLP studies
• ISO/IEC 17025 and CLIP-accredited diagnostic laboratories and ISO 17034 reference material laboratories with internal quality management system

Animal Model Development

• Testing and evaluation of leading MCM candidates to support data packages for FDA submission
• State-of-the-art, GLP compliant aerosol challenge capabilities
• Animal efficacy studies performed in BSL-3 and BSL-4 laboratories
• Industry-leading veterinary pathology team leverages live data capture and reporting in the laboratory
• Extensive telemetry and veterinary surgery capabilities

Diagnostic Assay Development

• Pre-analytical and pre-clinical testing of diagnostic systems in advanced development
• Developing and fielding diagnostic capabilities to fill operational gaps
• Preparing FDA submissions for DoD diagnostic medical countermeasures
• Pre-Emergency Use Authorization (EUA) initiative for high-consequence pathogens
• Data packages pre-positioned with FDA support faster turnaround of EUA for outbreaks/contingencies