Chapter 31 : Biosafety in the Pharmaceutical Industry

Abstract:

Pharmaceutical companies that employ pathogenic microorganisms to produce vaccines and sometimes pharmaceuticals must establish a broad range of biosafety practices to ensure the safety of their employees as well as their products. At the drug discovery stage, especially during the search for candidates from natural sources, these safety practices must allow the research laboratories to cultivate myriad microorganisms, many of which are initially unknown. During scale-up, the biosafety practices employed should be in harmony with international guidelines to ensure that the manufacturing process and product may be implemented and sold, respectively, in other countries. Because the biosafety concerns experienced in pharmaceutical research laboratories are quite similar to those discussed in earlier chapters, they will not be repeated here. Therefore, this chapter briefly addresses the biosafety challenges commonly experienced in cultivating recombinant and pathogenic microbes. The use of mammalian cells for the production of therapeutic proteins and viruses will also be addressed.