Chapter 30 : Biosafety in the Pharmaceutical Industry

Abstract:

This chapter addresses the biosafety challenges commonly experienced in cultivating recombinant and pathogenic microbes and the use of mammalian cells for the production of therapeutic proteins and viruses. It summarizes the place and application of viruses, bacteria, and fungi in pharmaceutical research and development. Recombinant viral agents have become a significant starting material for both gene therapy and vaccine production. Recombinant bacteria are frequently used to produce pharmacological proteins, enzymes, and plasmid DNA. The two bacterial species most frequently employed are Escherichia coli and Bacillus subtilis. Containment for fungi and yeasts can vary from biosafety level 1 (BSL-1) for organisms such as Saccharomyces cerevisiae through BSL-3 for Histoplasma species. Containment for known fungi should follow the recommendations provided by national guidelines, such as in Biosafety in Microbiological and Biomedical Laboratories (BMBL). Mammalian cells may be used for the direct generation of pharmacological proteins, usually created by recombinant DNA techniques. The biosafety regulations utilized at a specific company are frequently dictated by the home country for the organization. Clinical assays can present challenge for the biosafety professional within the pharmaceutical industry. The global harmonization of biosafety practices would allow benchmarking to determine the best practices for this industry.