ABSTRACT
This chapter addresses the aseptic processing of biopharmaceuticals derived from recombinant technology. The discovery and application of the biopharmaceuticals has progressed if exceeded traditional pharmacologic formulations. Biopharmaceuticals differ from traditional pharmaceutical indications in that they act in the same manner as the compound that occurs naturally in the body. Mammalian cell culture suspensions, which are used for the production of specific monoclonal antibodies, are generated by the fusion of eukaryotic cells with tumor cells. Prokaryotic and eukaryotic cell systems need to be preserved in an adequate manner to ensure continued proliferation of the host cell line. The stability of the strain is critical at all phases of the product development process. The chronology of the field of process fermentation includes the first large-scale batch production breweries of the 1700s, through the war-driven 1940s era with the manufacture of the first commercial antibiotics.
