In the last few decades, laboratory and therapeutic applications of cell culture-derived biologicals have expanded from their use in diagnostic and research fields to the prevention and treatment of infectious diseases, certain forms of cancer, immunological and congenital conditions, and cell and gene therapy. While significant therapeutic benefits obtained from the use of cell culture-derived biologics (e.g., recombinant proteins, monoclonal antibodies [mAb], and vaccines) are unequivocal, the complexities associated with the manufacture of such products is acknowledged. Primary and continuous cell lines used in the manufacture can be associated with risk of contamination with endogenous retroviruses, latent viruses, or new and emerging agents. Some cell lines, such as Chinese hamster ovary (CHO) cells, have an excellent safety record with no documented safety risks…
Tag: <span>perfusion bioprocessing</span>
Economic conditions are driving a greater demand for improvements in productivity, cost management, and outsourcing. Technology also continues to advance and change the biomanufacturing environment. This was documented in the recently released 2010 7th Annual Report and Survey of Biopharmaceutical Manufacturing with input provided by 327 biomanufacturers globally. “Productivity improvements” is the #1 area where companies have been focusing on resources this year. The survey also documents an evolutionary change in the basic approaches and technologies used for upstream bioprocessing. While in recent years, the industry has largely been dominated by fed batch (or batch fed) bioprocessing, with fermentation performed in a bioreactor containing the same medium until ready for harvest, the BioPlan survey shows a definite shift towards greater acceptance and use of perfusion bioprocessing…