This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts. The key difference between the chemical reactor and the bioreactor is that the chemical has a finite life in the vessel, while the biological agent is adaptive to our planet and humanity. The diversity and complexity of pharmaceutical products developed over the years have pushed the research to explore the enormous variety of bacteria, fungi, viruses, and animal forms (including the exotic) on the earth. We utilize cell cultures from humans, insects, plants, and animals and with impunity genetically engineer them for our therapies. We must therefore practice a very careful assessment of our biological processes and develop robust containment strategies and designs for the safety of our environment and personnel.

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