Preclinical Vaccine Development: Implementing the Food and Drug Administration’s Good Laboratory Practices in a Biocontainment Environment—A University BSL3/BSL4 Laboratory Perspective

The recent surge in awareness of biodefense-related and emerging infectious disease agents has created a demand for development and subsequent evaluation and testing of vaccines as well as therapeutic and diagnostic products for pathogens that require high (biosafety level 3) and maximum (biosafety level 4) biocontainment. For many of these products, human clinical trials may never be practical, so significant emphasis has also been placed on the potential for their approval by the US Food and Drug Administration using new mechanisms such as the “Animal Rule” and Emergency Use Authorization. As a result, preclinical in vitro and animal testing performed in compliance with the Good Laboratory Practice (GLP) regulations may be the sole source of data to support licensure of these products. This chapter aims to provide a background to the scope, intentions, and requirements of the US GLP regulations, as defined by 21 CFR Part 58, and provide some practical considerations for establishing the necessary policies and procedures to conduct GLP-compliant studies under high and maximum biocontainment.